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

Regulatory Submission Specialist, SDE LCM

The Regulatory Submission Specialist, Submission Delivery Excellence (SDE), Life...

Location

Mexico , Mexico City

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Degree in a biological, healthcare, or scientific discipline (or equivalent experience in Regulatory Affairs)
Solid understanding of pharmaceutical development, R&D processes, product registration, and lifecycle management
Proven ability to interpret and apply regulatory frameworks and translate requirements into compliant submission strategies
Fluency in Spanish (written and spoken) with experience preparing and reviewing regulatory documentation and MSRs in Spanish
strong professional communication skills in English
Experience working in global, matrix environments, effectively engaging cross-functional teams and management levels
Strong organizational skills, attention to detail, risk-based thinking, and ability to manage shifting priorities while delivering high-quality outputs on time.

Job Responsibility

Lead end-to-end delivery of marketing applications and lifecycle maintenance submissions (renewals, variations, site registrations) in compliance with Regulatory Authority requirements, internal SOPs, and agreed timelines
Coordinate, author, and review Local Operating Company (LOC) Market-Specific Requirements (MSRs) — including documentation in Spanish — ensuring alignment with global dossier strategy and local regulatory expectations
Execute and support regulatory submission strategies across multiple scenarios, independently managing dossier planning, documentation readiness, and cross-functional inputs
Identify, assess, and proactively escalate submission-related risks with potential business impact, implementing mitigation plans to protect timelines and approvals
Apply regulatory guidelines, policies, and pharmaceutical manufacturing/registration requirements to ensure high-quality, compliant submissions
Lead or co-lead multidisciplinary discussions related to submission content, resource planning, timelines, lifecycle management, and continuous process improvement initiatives.

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

Fulltime

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

Manager, Early Development Regulatory Lead

This position represents one or more Regions / Countries on the Regulatory Sub t...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D
minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
Experience supporting and/or leading IND/CTA submissions
Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
Strong verbal and written communications skills
Excellent project and/or program management skills
Detail-oriented and ability to achieve results across functions and levels
Ability to work effectively across a highly complex, fast paced, matrix organization
Proficiency in MS Office Suite
Learning agility and 'scalability' to take on increasing responsibility as Intercept grows

Job Responsibility

Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset
Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
Contribute to development of regulatory submission plans
Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities
Support product development and lifecycle management activities
Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies
Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

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

Principal Packaging Engineer- Drug Product Design & Development

We are seeking an accomplished and forward-thinking leader to join our Biotherap...

Location

United States , St. Louis - Chesterfield; Andover

Salary:

106000.00 - 171500.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering or Science (Packaging, Mechanical, Materials, Biomedical, Chemical, Chemistry, Biochemistry, or related) with 12+ years of relevant experience
OR Master’s/MBA with 10+ years of experience
OR PhD with 8+ years of experience in pharmaceutical packaging development
Strong knowledge of parenteral packaging components and testing equipment (e.g., Instron, ZebraSci, Computrac, plunger movement chambers)
Experience in GMP and/or ISO 13485 environments
In-depth understanding of global regulatory and quality standards (FDA, ICH, ISO 13485, 11040, 10993, USP/EP/JP compendia, combination product regulations)
Ability to interface with regulatory agencies and provide sound technical justifications
Demonstrated success leading teams and cross-functional initiatives
Excellent written, verbal, and presentation skills
Strong project management and stakeholder engagement capabilities

Job Responsibility

Provide strategic direction and day-to-day leadership for laboratory operations supporting drug product and combination product development
Mentor, develop, and empower a high-performing team
Contribute to goal setting, performance reviews, and career development for packaging engineers
Act as the subject matter expert for laboratory operations, ensuring compliance with ISO 13485, GMP, and internal quality systems
Own equipment calibration and qualification activities
Ensure laboratory notebooks and electronic lab notebook (eLN) systems meet procedural, regulatory, and best-practice standards
Oversee and review testing activities, protocols, work instructions, lab notebooks, and technical reports for medical devices and combination products
Lead component and container closure system selection, qualification, and development activities
Author and support regulatory submission content and respond to packaging-related regulatory inquiries
Partner closely with Quality, Regulatory, EHS, Facilities, Manufacturing, and Global Workplace Solutions

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Content Regulatory Submission Lead

Senior Director, Clinical and Regulatory Writing

Regulatory Submission Specialist, SDE LCM

Director, Global Regulatory Affairs (Submission Project Management)

Regulatory Affairs Manager

Director, CMC Regulatory Affairs

Manager, Early Development Regulatory Lead

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

Principal Packaging Engineer- Drug Product Design & Development

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Content Regulatory Submission Lead

Senior Director, Clinical and Regulatory Writing

Regulatory Submission Specialist, SDE LCM

Director, Global Regulatory Affairs (Submission Project Management)

Regulatory Affairs Manager

Director, CMC Regulatory Affairs

Manager, Early Development Regulatory Lead

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

Principal Packaging Engineer- Drug Product Design & Development

Category:
IT - Administration

Contract Type:
Not provided

Job Posted:
January 29, 2026