CrawlJobs Logo

Senior Regulatory Affairs Project Manager I

United States, Austin · Job Posted January 20, 2026
Apply Position
Job Link Share

Job Description

ICON is seeking a highly motivated and dedicated Project Manager to work at the intersection of structural design and testing, overseeing the testing process for validation and regulatory acceptance of ICON's breakthrough 3D-printed structural systems and materials. Under the leadership of the Senior Regulatory Affairs Program Manager, this position is responsible for directing the validation and acceptance efforts, with a focus on achieving target schedules and budgets while working directly with external consultants, testing laboratories, and teammates to deliver completed test campaigns that systematically transform cutting-edge concepts into validated, approved solutions that unlock new markets and revenue opportunities. This role is based out of our Austin, TX campus, directly contributing to ICON's technology advancement and competitive positioning.

Job Responsibility

  • Develop and manage project schedules, cost estimates, and budgets for complex testing campaigns while tracking progress against milestones and managing scope changes
  • Direct and oversee comprehensive test plan development and specimen design that meets structural testing objectives and regulatory requirements for ICON's 3D printed systems
  • Develop and oversee the generation of detailed engineering documentation for print processes such as technical drawings, instructions, and logs, directing team members and consultants as needed
  • Coordinate with internal ICON departments including Testing, Hardware, and Operations teams to ensure testing is successfully completed while communicating project progress, blockers, and results to key stakeholders
  • Manage and oversee contracts with third-party laboratories, consultants, and vendors conducting advanced analysis, research, development, or manufacturing for ICON to ensure successful execution of the regulatory program goals and objectives. Including but not limited to testing logistics, shipping, proposal evaluation, cost negotiation, schedule coordination, performance oversight, and deliverable management
  • Participate in testing observations and coordinate with external stakeholders to gather real-time data while directing project teams and resolving scheduling conflicts
  • Conduct and oversee the analysis and interpretation of test results using advanced analytical techniques, guiding consultants and team members in identifying performance trends and developing design methodologies
  • Provide regular updates on project progress to the Regulatory Affairs Program Manager, and Director of Building + Construction Science
  • Support regulatory approval processes by directing established testing approaches, guiding development of new methodologies, and overseeing preparation of comprehensive technical documentation for regulatory bodies in accordance with the project schedule and budget

Requirements

  • Graduate degree in Civil Engineering, Structural Engineering, or a related technical discipline
  • 8+ years of relevant professional experience in structural design, testing, research, or construction with demonstrated project management responsibilities
  • Demonstrated experience managing multiple concurrent complex technical projects, including schedule development, budget management, and stakeholder coordination
  • Proven ability to work with and manage external consultants, laboratories, and vendors while maintaining quality standards and project deliverables
  • Strong understanding of structural engineering from first principles, including mechanics of materials, structural analysis, and design fundamentals
  • Practical experience in the design and testing of concrete and masonry structural systems and materials
  • Hands-on experience with structural testing equipment, including hydraulic cylinders, pumps, actuators, load frames, instrumentation, and data acquisition systems
  • Advanced problem-solving abilities and analytical thinking skills to assess complex technical challenges and develop effective solutions across multiple disciplines
  • Strong technical writing and communication skills with demonstrated ability to prepare comprehensive reports and present findings to diverse stakeholder groups
  • Familiarity with applicable structural testing standards, ACs, and codes, including ASTM, ACI, ASCE, and building code requirements
  • Field work and overnight travel is required

Nice to have

  • Professional Engineer (PE) license or eligibility to obtain PE licensure within 6 months of hire
  • Experience working with government agencies or regulatory bodies in technical approval processes
  • Understanding of concrete material science, including mix design, curing processes, fresh and hardened properties, and durability characteristics
  • Field construction experience, particularly with concrete and masonry construction methods, quality control processes, and construction tools
  • Experience with seismic loading analysis, seismic design code requirements, and seismic testing methodologies
  • Familiarity with 3D printing technologies, additive manufacturing processes, or advanced construction methods

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Senior Regulatory Affairs Project Manager I

8 matching positions

Senior Regulatory Affairs Project Manager I, MILCON

ICON is seeking a highly motivated and dedicated Sr. Regulatory Affairs Project ...
Location
Location
United States , Austin
Salary
Salary:
Not provided
iconbuild.com Logo
ICON
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Structural Engineering, Civil Engineering, Architectural Engineering, or a related technical field
  • 6+ years of relevant professional experience in structural engineering, construction, or regulatory affairs with demonstrated expertise in building code compliance
  • Strong understanding of building codes and standards, including UFC, IBC, IRC, ACI, ASCE, AISC, NDS, and TMS, with proven ability to interpret and apply complex regulatory requirements across federal and military jurisdictions
  • Demonstrated experience navigating federal regulatory approval processes with government agencies, which includes one or a combination of submission preparation, technical review coordination, and approval facilitation
  • Strong technical knowledge of structural systems and their integration with building enclosures, MEP systems, and construction methods for residential, commercial, and government buildings, with emphasis on concrete and masonry construction
  • Experience working with federal agencies, DoD organizations, or military construction projects with a general understanding of government contracting and acquisition processes
  • Understanding of structural testing methodologies and ability to develop test plans, analyze results, and prepare technical validation reports
  • Excellent verbal and written communication skills with proven ability to present complex technical information to government stakeholders, military officials, and internal teams
  • technical writing skills with ability to prepare code compliance documentation and regulatory submissions
  • Exceptional relationship-building and networking abilities with demonstrated success establishing trust and credibility with government agencies and federal stakeholders in professional and regulatory environments
Job Responsibility
Job Responsibility
  • Execute public sector regulatory efforts by aligning regulatory pathways with government building codes and standards. Accelerate adoption of concrete 3D-printed construction across federal and state agencies, DoD military construction (MILCON), and intelligence community customers
  • Build and maintain strong working relationships with federal technical groups —including USACE, NAVFAC, AFCEC, and other federal regulatory bodies—through presentations, and technical engagement
  • Support business development requests preparing technical proposals, delivering customer technical presentations, and technical demonstrations as needed
  • Serve as the primary regulatory contact for government projects and ICON customers working with federal agencies. Provide technical guidance, address regulatory questions, and resolve complex approval challenges
  • Lead regulatory acceptance and approval processes to incorporate ICON's technology into government building standards, including the Unified Facilities Criteria (UFC). Coordinate testing programs, manage agency interactions, and develop technical documentation that meets federal requirements
  • Coordinate regulatory testing and technology validation efforts required for federal market access. Ensure testing programs meet UFC requirements, support approval objectives, and align with project timelines
  • Conduct comprehensive federal code research and analysis to identify regulatory requirements, approval pathways, and potential barriers across UFC, federal building codes, and agency-specific standards. Synthesize findings to inform business development strategy
  • Collaborate with internal technical teams—including testing, materials science, product engineering, and operations—to integrate federal regulatory requirements into product development
  • ensure validation efforts support approval pathways and resolve technical challenges that impact government acceptance
  • Work with internal teams to resolve post-occupancy technical issues related to ICON's wall systems and building technology on government projects
  • Fulltime
Read More
Arrow Right

(Senior) Manager, Regulatory Affairs

We are working with a leading pharmaceutical company who are seeking an experien...
Location
Location
United Kingdom , Maidenhead
Salary
Salary:
70.00 - 85.00 GBP / Hour
srgtalent.com Logo
SRG
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences discipline
  • Strong experience in European Regulatory Affairs, including centralised, MRP/DCP and national procedures
  • Proven track record leading regulatory activities for development products (e.g., scientific advice, PIP)
  • Effective communicator able to work across complex international and matrixed environments
  • Strong leadership, organisational skills and ability to work independently with minimal supervision
Job Responsibility
Job Responsibility
  • Lead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe Area
  • Represent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategy
  • Collaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activities
  • Assess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvals
  • Monitor evolving European legislation and lead the development of regulatory responses and policy implementation
  • Parttime
Read More
Arrow Right

Senior Manager, Regulatory Affairs

Location
Location
India , Thane
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
June 30, 2026
Flip Icon
Requirements
Requirements
  • Expert in Regulatory submissions in India
  • Minimum 12 years experience
  • Ability to translate strategical goals into tactical goals
  • Structured, analytical, systematic and independent way of working
  • Lead extensive project reengineering activities
  • Demonstrable ability in leading, mentoring, managing and motivation of staff
  • Ability to lead project teams
  • Ability to manage internal and external (client) relationships
  • Very good communication skills (written and verbally)
  • English business fluent
Job Responsibility
Job Responsibility
  • Develop and maintain strong client relationships
  • Participation in regulatory processes to gain and maintain marketing authorizations
  • Preparation, review and compilation of documents within the framework of regulatory affairs projects
  • Communication with clients and Health Authorities
  • Support with scientific advice procedures and representation of clients
  • Responsible for the planning and execution of client projects
  • Coordination of project teams
  • General guidance (consultancy) regarding Regulatory Strategy and Procedure Management
  • Regulatory intelligence
  • Present seminars and lectures
  • Fulltime
!
Read More
Arrow Right

Senior Manager, Regulatory Affairs

Beam is seeking a Sr Manager/Manager Regulatory Affairs to progress a broad port...
Location
Location
United States , Cambridge
Salary
Salary:
155000.00 - 190000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in a medical or scientific field required
  • Strong grasp of drug development lifecycle and strategy
  • A minimum of 5 years of experience working in Regulatory Affairs
  • Knowledge of US and global regulatory procedures and practices
  • Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
  • Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
  • Ability to develop and maintain collaborative working relationships with internal and external partners
  • Excellent written/verbal communication skills, attention to detail, organizational skills
Job Responsibility
Job Responsibility
  • drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines
  • Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
  • Maintain and update regulatory submission plans, timelines, and other core strategic documents
  • represent Regulatory Affairs on cross functional and project teams to ensure regulatory input into non-clinical, clinical and commercial strategies
  • Guide and assist on the planning, preparation, writing and submission of regulatory documentation
  • Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
  • Fulltime
Read More
Arrow Right

Senior Manager, Regulatory Affairs

The mission of the Regulatory Affairs group is to implement effective processes ...
Location
Location
United States , St Louis
Salary
Salary:
122187.50 - 158125.00 USD / Year
steris.com Logo
STERIS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree
  • 7 years of Regulatory Affairs experience
  • Minimum of 7 years of US EPA Antimicrobial registration experience
  • US State Registration experience
  • Leadership experience managing a team of people
  • Ability to travel as noted above
Job Responsibility
Job Responsibility
  • Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compliance requirements for marketing STERIS products in their assigned areas or regions where STERIS does business
  • Effectively interface with government agencies, notified bodies, consultants and authorized dealer representatives as necessary to address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management
  • Provide regulatory guidance and support to project teams and STERIS internal Customers to support new product development and existing product lines in support of registration requirements.
  • Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified.
  • Gather information and documentation on new or modified products to determine submission requirements for particular markets.
  • Compile and create document registration packages through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities.
  • Critically assess the strength and completeness of documentation created by others
  • advise improvements to comply with current requirements for particular regulatory authorities.
  • See that all direct team members maintain submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Report to management concerning current, pending, and re-registration approvals. Identify and take action on any unexpected delays
What we offer
What we offer
  • Market Competitive Pay
  • Extensive Paid Time Off and (9) added Holidays
  • Excellent Healthcare, Dental and Vision Benefits
  • Long/Short Term Disability Coverage
  • 401(k) with a company match
  • Maternity and Paternity Leave
  • Additional add-on benefits/discounts for programs such as Pet Insurance
  • Tuition Reimbursement and continued education programs
  • Excellent opportunities for advancement in a stable long-term care
  • Fulltime
Read More
Arrow Right

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...
Location
Location
Singapore
Salary
Salary:
Not provided
avanos.com Logo
Avanos
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a relevant scientific or technical discipline
  • 6-10 years of experience in the medical device industry
  • Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives
  • Strong written and verbal communication skills
  • Experience with regional or international regulatory submissions preferred
  • Strong computer proficiency
  • Understanding of regulatory requirements across major APAC markets
  • Familiarity with mandatory Quality Management System requirements across APAC
  • General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage
Job Responsibility
Job Responsibility
  • Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates
  • Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region
  • Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
  • Provide Regulatory and Quality leadership across all APAC markets
  • Recruit, build, and develop in-country RA/QA teams
  • Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements
  • Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC
  • Maintain regulatory databases
  • Direct the development and maintenance of regulatory systems and processes
  • Develop APAC regulatory strategies
What we offer
What we offer
  • comprehensive and competitive range of benefits
  • health care benefits
  • retirement plans
  • work/life benefits
Read More
Arrow Right

Senior Regulatory Affairs Manager

Facilitates and supports the regulatory and drug development requirements of ext...
Location
Location
United States , Shawnee
Salary
Salary:
Not provided
argentaglobal.com Logo
Argenta
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred
  • 8+ years experience in veterinary regulatory and/or animal drug development
  • Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA
  • Development and regulatory experience with food animal drugs is preferred but not required
  • Good written and oral communication skills, and ability to work collaboratively within and across teams
  • Results and bottom line oriented
  • Excellent analytical skills and attention to detail
  • Proven influence, negotiation and persuasion skills
  • Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs
Job Responsibility
Job Responsibility
  • Facilitates and supports the regulatory and drug development requirements of external clients and internal projects
  • Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications
  • Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges
  • Creates regulatory solutions to complex issues
  • Provides client accurate expert regulatory advice on animal health product development
  • Represent Argenta in industry associations (e.g. GADA, AHI, SQA)
  • Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications
  • Fulltime
Read More
Arrow Right

Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

This position is responsible for leading CMC regulatory activities for investiga...
Location
Location
United States; Belgium; Italy; United Kingdom , Collegeville; Wavre; Durham; Siena; London; Waltham
Salary
Salary:
144375.00 - 240625.00 USD / Year
us.gsk.com Logo
GSK
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Life Sciences or related field
  • Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise
  • Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
  • Two or more years of experience completing project management tasks.
Job Responsibility
Job Responsibility
  • Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements
  • Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies
  • Mentors or trains staff
  • May have direct line management responsibility
  • Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate
  • Provides strategic direction, data assessment and conclusions within and across departments
  • Able to establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organisation
  • Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment)
  • May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs)
  • Has accountability for submission content
What we offer
What we offer
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Fulltime
Read More
Arrow Right