Senior Regulatory Affairs Consultant

Senior Regulatory Affairs Consultant - Regulatory Intelligence

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
Project management / leadership experience
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills

Job Responsibility

Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
Regularly search the public domain for competitor product regulatory developments and report the most critical findings
Inform client immediately of any changes to the regulatory environment directly affecting client’s business
Search for non-compliance letters or notices for client’s suppliers and provide a regular report
Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Malaysia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Fluent in local language, English, oral and written
Expert MS Office skills
Excellent organizational, time management and interpersonal skills in a global environment
Ability to work successfully in a complex global matrix organization
Proven ability to work effectively both independently and in a team
The expertise, determination and courage to resolve or escalate issues as appropriate
Subject matter expert in job area typically obtained through advanced education and work experience
Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
Partner management experience: proven experience in managing relationships with third-party vendors
Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive

Job Responsibility

Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards
monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary
develop risk mitigation strategies and implement controls to minimize risks associated with partner activities
Act as point of contact for escalations and issue resolution related to partner activities
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team
participating in policy activities with industry groups and trade associations
Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
Keep internal data bases up to date with local activity and ensure compliance KPIs are adequately kept on track
Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs

What we offer

Flexible work arrangements

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Senior Regulatory Affairs Consultant - Labelling

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Strong knowledge of EU regulatory requirements for product labelling and promotional materials
Experience with electronic content management systems and regulatory SOPs
Excellent project management and organizational abilities
Outstanding written and verbal communication skills
Proven ability to work effectively in cross-functional teams
Fluent in English, written and spoken

Job Responsibility

Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
Serve as the key point of contact for EU Product Information for both internal and external stakeholders
Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
Deliver competitive labelling searches and contribute to TLP for early development assets
Ensure timely tracking and management of all EU Product Information in appropriate systems
Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
Coordinate Linguistic Review processes with LR Coordinator according to SOPs
Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes
Lead the Local Labelling Committee for creation, review and approval of EU Product Information
Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Project Manager I

ICON is seeking a highly motivated and dedicated Project Manager to work at the ...

Location

United States , Austin

Salary:

Not provided

ICON

Expiration Date

Until further notice

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

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

Fulltime

Senior Regulatory Consultant - Regulatory Project/Program Manager

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BA/BS degree in a scientific, engineering, or healthcare discipline required
advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred
Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management
Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities
Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations
Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities
Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy
Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders
Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight
Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams

Job Responsibility

Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing
Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making
Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs
Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives
Collaborate closely with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies
Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution
Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key decisions and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately
Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams
Anticipate and troubleshoot complex regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness
Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights

What we offer

Flexibility of working remotely
Supportive and dynamic team
Challenging assignments
Mentorship from experienced regulatory professionals
Opportunities for career growth
Diverse and global client exposure
Learn from experts
Flexible work arrangements

Fulltime

Senior Regulatory Affairs Manager

Facilitates and supports the regulatory and drug development requirements of ext...

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

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

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

Senior Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in Pharmacy preferred
+3 years of experience in pharmaceutical, medical device or health industry
Experience in regulatory affairs or relevant discipline is preferred
Solid understanding of drug development
Good knowledge of National Drug Regulations and Procedures
English Proficiency
Good communication skill for external and internal interaction
Good computer literacy skills, comfortable working with database

Job Responsibility

Achieve timely & successful product registration in accordance with corporate & local strategies
Collect any information on new regulations and guidelines and share it in local RA team
Ensure compliance with company regulatory policies, regulations and procedures
Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting
Manage all regulatory tasks & projects including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
Develop local registration plans in alignment with local business and global regulatory strategy
Monitor progress of submission & coordinate timely responses to all questions from health authorities
Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
Management of regulatory submissions to support clinical trial activities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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Senior Regulatory Affairs Consultant - Project Management

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