Regulatory Writing Senior Manager Job at Amgen

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manager, Regulatory Affairs (Ad Promo)

As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse cli...

Location

United States , Raleigh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience
US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry
Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction
Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail
Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

Job Responsibility

Participate in provision of regulatory expertise in strategic drug development across multiple areas
Take part in preparation of strategic development and submission plans
Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally)
Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities
Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices

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

Senior Manager, Regulatory Capital, and Liquidity

Under general direction, the Senior Manager of Regulatory Capital and Liquidity ...

Location

United States , Saint Petersburg

Salary:

Not provided

Raymond James

Expiration Date

Until further notice

Requirements

Knowledge of Company’s working structure, policies, mission, and strategies
Knowledge of Advanced accounting concepts, practices and procedures
Knowledge of Financial Services and Treasury Operations
Knowledge of Statistical Modeling and Methods
Knowledge of Controls and implementation of controls as they relate to regulatory reporting
Skill in Reviewing, interpreting and analyzing financial statements
Skill in Project management
Skill in Preparing management reports
Skill in Promoting effective coordination between department and other functional areas
Skill in Interpreting and applying policies and procedures

Job Responsibility

Lead the execution of capital and liquidity risk management strategies in alignment with regulatory requirements and internal risk appetite
Oversee the preparation and submission of regulatory reports (e.g., FFIEC) ensuring accuracy, timeliness, and compliance
Implement capital planning strategies, including internal capital adequacy assessments and contingency funding plans
Prepare short- and long-term liquidity projections to support proactive financial planning, while continuously monitoring liquidity positions and key risk indicators (KRIs) to ensure alignment with risk appetite and regulatory expectations
Manage business unit-level liquidity forecasting and stress testing initiatives, including the preparation of scenario models and thorough documentation of underlying assumptions and methodologies to support informed decision-making and risk mitigation
Identify and implement process improvements to enhance efficiency, accuracy, and control in capital, liquidity and regulatory reporting functions
Lead the Capital Planning Committee (CPC) with analysis, reporting, and recommendations
Participate in strategic planning and analysis and special projects
Manage and execute on the annual budgeting process aligning with strategic business goals
Review financial performance results, analyze variances to budget, and provide actionable insights to executive leadership

Fulltime

Senior Manager, Regulatory Affairs

Beam is seeking a Sr Manager/Manager Regulatory Affairs to progress a broad port...

Location

United States , Cambridge

Salary:

155000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

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

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

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 Affairs Project Manager I, MILCON

ICON is seeking a highly motivated and dedicated Sr. Regulatory Affairs Project ...

Location

United States , Austin

Salary:

Not provided

ICON

Expiration Date

Until further notice

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

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

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Manager / Senior Manager - Financial Services Consulting - Information Technology

Location

Hong Kong , Hong Kong

Salary:

Not provided

Forvis Mazars

Expiration Date

Until further notice

Requirements

University degree majoring in Finance, Accounting, Business, Legal, Information Systems, Computer Science/ Engineering or related subjects
Minimum 4-5 years’ experience gained in professional services firms, commercial banks or other financial institute experience will be an advantage
Demonstrate good analytical, problem solving and presentation skills. Flexible, self-starter possessing intellectual curiosity. Effective time and project management with excellent interpersonal skills
Keen on career development on any of the following areas: financial services regulatory consulting, compliance, governance and internal controls, risk management, operational / technology risk management, business & system processes review, internal audit, cyber-security and business consulting
Interested in gaining experience in any of the following industries: Banking and capital markets (client on-boarding / KYC / AML / investment product suitability and other regulatory compliance, front office activities in products / sales channels, middle and/or back office control, operational / technology risk management – commercial banking, private banking, investment banking)
Asset management (distribution channels, controls and processes – prime brokerage, fund administration, fund management (retail, institutional, and/or real estate / private equity, etc.))
Digital asset management/ trading (Cybersecurity, custodian management, licensing requirements)
Insurance (underwriting, claims, reserving, Solvency II, policy administration systems – general or life insurance)
Payment industry (Cybersecurity, settlement and clearing)
Ability to identify and assess business process controls and linkage to IT systems

Job Responsibility

Lead a client-centric advisory team in financial services industry
Support the development on consulting engagement plans and project approaches, analyse client’s current business processes and understanding the risk management environment for financial institutions
Support the planning, execution and delivery of consulting engagements covering regulatory, operational and IT advisory with FS clients in areas such as client onboarding, KYC, AML, system architecture/ pre- or post-implementation, reviews
IT regulatory & licensing reviews (e.g. cybersecurity requirements on C-RAF and iCAST requirements, IS guideline, MCRA membership application, etc.)
Utilise your skills in the areas of structured problem solving, business analysis, analytics, design thinking and lean process improvement to help our FS clients drive profitability and performance through their business operations
Use of technology and data including FinTech/ RegTech/ InsuTech innovation with respect to financial institutions to promote innovation and achieve regulatory compliance
Support change management including the revision or formulation of new policies, systems and controls aligned with regulatory requirements and regulators’ expectations
Plan, execute and communicate with engagement stakeholders of the financial institutions
Identify current and emerging trends of regulatory requirements for the financial services sector in Hong Kong, Singapore, Mainland China and other Asian markets and global regulatory expectations

What we offer

medical and dental insurance
life insurance
a 5-day working week
discretionary performance bonus
birthday leave
marriage leave

Fulltime

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Regulatory Writing Senior Manager

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