Content Regulatory Submission Lead Job at Zeektek

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

Director, Global Regulatory Affairs (Submission Project Management)

The Director of Global Regulatory Affairs (Submission Project Management) is res...

Location

United States , Waltham

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years (8+ with advanced degree) of regulatory affairs and/or project management experience
Proven track record managing global submissions (NDA, BLA, MAA)
Deep expertise in the integrated drug development process, ensuring seamless progression from discovery through commercialization
Collaborated effectively across multidisciplinary teams to identify innovative solutions and alternatives, driving positive business outcomes
Expertly assessed and mitigated risk within a highly regulated environment, maintaining compliance while advancing critical projects
Strong project management skills (PMP certification a plus), with proficiency in Microsoft Project, SmartSheet, or Planisware
Excellent communication, organizational, and leadership abilities
Ability to thrive in a fast-paced, deadline-driven environment
Demonstrated negotiation and influence skills
Bachelor’s degree with regulatory and/or project management experience in the pharmaceutical industry

Job Responsibility

Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
Provide guidance on evolving global regulatory landscapes, including guidelines, regulations, and other factors related to regulatory filings
Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
Oversee project team delivery of the marketing authorization applications
Liaising with regulatory operations department to ensure all components are identified on the submission content plans and submissions meet technical, formatting, and compliance standards
Develop and manage marketing authorization project timelines and deliverables
Identify risks and manage operational risks, implementing mitigation/contingency strategies to ensure submission success
Track progress and report status updates to executive leadership
Establish best practices and SOPs as needed for marketing application related submission processes
Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime

Regulatory Affairs Manager

The RA Manager supports Global Reg Teams in the development and execution of glo...

Location

United States

Salary:

51.00 - 75.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
4+ year experience
Nonclinical / Clinical Regulatory Affairs experience preferred

Job Responsibility

Support the development of the nonclinical / clinical regulatory strategy and plan
Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions
Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials
With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions
Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances
Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review
Collaborate with Reg PM to create and align submission timelines
Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA

What we offer

discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans

Director, CMC Regulatory Affairs

Reporting to the Vice President, CMC Regulatory, the Director of Regulatory Affa...

Location

United States , Waltham

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years regulatory CMC experience, including experience as a regulatory CMC product lead, or equivalent industry experience
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams
Able to work independently and complete projects with minimal oversight, escalating issues to regulatory management with discretion
Self-starter and results-oriented individual with outstanding work ethic
must be able to perform in a fast-paced environment
Demonstrates leadership, problem-solving ability, attention to detail, flexibility, and values teamwork
Exercises good judgement in elevating and communicating actual or potential issues to line management
Ability to multi-task and adjust priorities quickly while working under tight deadlines
Experience using electronic document management systems and document review tools

Job Responsibility

Responsible for one or more product(s) and supports the regulatory CMC team in the development & execution of global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities
Define CMC content (data and documentation) requirements for regulatory submissions and conformance with established requirements
Leads CMC preparation activities for meetings with Health Authorities on CMC related matters
Ensure timely preparation of CMC documents and responsible for handing off submission ready documents for regulatory submissions
Contribute to the evaluation of change proposals for global regulatory impact and support planned global variations and amendments
Identify and communicate critical topics and risk promptly to the regulatory CMC team
Oversee the copyediting, finalization, approval, and hand-off of documents for publishing

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Director, Regulatory Affairs - In-Vitro Diagnostics (IVD)

Amgen is seeking a Director of Regulatory Affairs to work in their Thousand Oaks...

Location

United States , Thousand Oaks

Salary:

210840.00 - 251128.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly related experience
Master’s degree and 7 years of directly related experience
Bachelor’s degree and 9 years of directly related experience
Substantial experience leading CMC/Device Regulatory Affairs strategy and execution for products in differing stages of the product lifecycle
Experience of leading and/or participating in meetings with regulators in major markets (US, EU, Japan and China)
Knowledge of global CMC/Device regulations and understanding of evolving challenges and health authority expectations
Track record as a strong coach and mentor

Job Responsibility

Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting a culture of inclusion, diversity, and collaboration
Oversee resource allocation and operational strategies to effectively support the complex development pipelines
Develop regulatory positions, best practices, and SOPs to ensure efficient support for submissions and approvals
Lead cross-functional and global teams on regulatory issues, ensuring seamless communication and collaboration across all stakeholders
Lead the team to navigate IVD/CDx regulatory pathways, including the drug/diagnostics co-development process, clinical performance studies, analytical validations, and post-market compliance
Direct the team to develop and execute regulatory planning and submissions (e.g., PMA, 510(k), IDE) to achieve approvals across multiple regions, including the US, EU, Japan, and China
Collaborate with diagnostic partners on co-development programs, ensuring alignment and compliance
Utilize regulatory tools, such as databases and frameworks, for efficient content planning and reporting
Ensure the team’s adherence to regulations, guidance and international standards, including ISO 13485, ISO 14971, and CLSI guidelines
Design and implement global regulatory strategies that align with business goals and product development timelines

What we offer

A 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
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Regulatory Affairs Specialist

Biocomposites is an international medical devices company that engineers, manufa...

Location

United Kingdom , Keele

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in a life science or equivalent field
Minimum 2-5 Years’ experience within Medical Devices Regulatory or Quality
Ability to read and understand medical device regulatory requirements and/or standards
Ability to review audit reports and action accordingly
Understanding of post market surveillance and/or clinical report writing
Ability to prioritise large amounts of changing, complex workload from multiple sources and make timely and effective decisions for the execution of project objectives
Takes accountability for the achievement of business goals and objectives
Has the ability to work independently

Job Responsibility

Creates and maintains global regulatory submissions to support timelines for new/modified product launches/registrations
Leads registrations and submissions for new and existing products
Ensures conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
Provide Regulatory Affairs support during internal and external audits
Liaise with regulatory authorities and Notified Bodies as required
Report, assess and communicate any changes in regulations
Provides regulatory assessment on complaints
Support Regulatory Affairs Manager in creation and maintenance of procedures
Act as mentor to junior regulatory staff members
Support and act as delegate for activities falling under the remit of the Regulatory Affairs Manager

What we offer

Competitive salary and benefits
Company events
Company pension
Employee discount
Free or subsidised travel
Free parking

Regulatory CMC Project 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

Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management)
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls)
Strong project management skills with a track record of managing complex projects and meeting deadlines
Excellent organizational and communication skills
Excellent time management abilities
Proficient in Microsoft Office Suite
Proven experience with project management software ie. Smartsheet
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones

Job Responsibility

Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards
Health Authority Engagement: Support the preparation of materials for health authority engagements

What we offer

Flexibility of working remotely
Part of a supportive and dynamic team
Supportive and inclusive environment
Opportunities for career growth
Flexible work arrangements
Diverse and global client exposure
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Senior Account Executive

The Sr. Account Executive (SAE) is a key contributor within the Client Services ...

Location

United States

Salary:

Not provided

Fingerpaint Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree, preferably in health sciences, marketing, or communications
4-6 years of work experience in a healthcare, marketing, or communications agency
Strong communication, relationship-building, and strategic thinking skills
Excellent organizational skills, attention to detail, and follow-through
Competency in presentation skills
Strong experience with project management software (e.g., Workamajig (preferred), Airtable, Jira) is a critical requirement
Proficient in Microsoft Word, intermediate-level Excel and PowerPoint
Ability to travel at least 1-3 time per year to meet with clients

Job Responsibility

Build and maintain strong professional relationships with clients and medical experts (faculty), adapting communication styles to diverse personalities and effectively defending agency positions
Lead project planning, track deliverables, and manage timelines to ensure high-quality execution from inception to completion
Act as the primary point of contact for stakeholders, providing proactive updates on project status, managing expectations, and navigating potential risks
Demonstrate a foundational understanding of disease states, products, and industry best practices to support client strategy and project execution
Maintain rigorous standards for documentation, including the prompt and accurate delivery of client contact reports, meeting summaries, and project tracking logs
Initiate and drive the full project lifecycle—from developing scopes, deliverables, and timelines to orchestrating day-to-day execution and ensuring high-quality delivery
Develop project estimates and manage daily finances, including budget tracking, scope change monitoring, weekly burn reports, and monthly forecasting/billing
Oversee project infrastructure, including job setup in Workamajig, maintenance of project files, and management of the Veeva submission process for internal and external stakeholders
Proactively identify project risks and monitor staff resourcing
collaborate with Operations and Account leads to ensure adequate coverage and project momentum

Content Regulatory Submission Lead

Zeektek

Location:

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 29, 2026

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