Director, CMC Regulatory Affairs Job at Kailera Therapeutics (Waltham)

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Director of Regulatory Affairs, CMC

Hemab is seeking a Director of Regulatory Affairs, CMC to lead global regulatory...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences, chemistry, engineering, or related scientific discipline required
Advanced degree (MS, PhD, PharmD) preferred
8+ years of pharmaceutical/biotechnology industry experience with at least 5 years in regulatory affairs with significant CMC focus, or equivalent combination of technical CMC and regulatory experience
Demonstrated experience with biologics CMC regulatory submissions (INDs, BLAs) and successful health authority interactions
Track record of developing successful CMC regulatory strategies for complex biologics and/or peptides through various stages of development
Experience with preparing global regulatory submissions to FDA and EMA as well as ex-US/EU regulatory Agencies (e.g., PMDA, Health Canada)
Familiarity with submission requirements for Regulatory Agencies in Middle East, Latin America and Asia is highly desirable
Deep understanding of global CMC regulatory requirements and guidance documents for biologics, including ICH guidelines (Q5, Q6, Q8-Q11)
Strong scientific acumen with ability to understand and communicate complex technical CMC information
Demonstrated ability to think strategically while managing tactical execution

Job Responsibility

Lead the development and execution of global CMC regulatory strategies for biologic products, including gene therapies
Serve as the CMC regulatory representative on cross-functional project teams, providing strategic input and guidance
Author and/or review CMC sections of regulatory submissions including INDs, CTAs, BLAs/MAAs, and amendments
Collaborate closely with CMC technical teams (Process Development, Analytical Development, Manufacturing, Quality)
Lead CMC regulatory aspects of health authority interactions, including preparation of briefing documents, responses to agency questions, and participation in regulatory meetings
Proactively identify CMC regulatory risks and develop mitigation strategies
Provide regulatory assessment and strategic guidance for CMC changes throughout the product lifecycle
Oversee CMC regulatory activities conducted by external vendors and consultants
Monitor evolving global CMC regulatory landscape, guidelines, and precedents
Partner with Quality Assurance to ensure CMC activities align with GMP requirements and support regulatory inspections readiness

Fulltime

Director, CMC and Device Regulatory Affairs

The Director, CMC and Device Regulatory Affairs will lead the implementation of ...

Location

Salary:

220000.00 - 240000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum of 10 years of industry experience
At least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
Proven track record of leading cross-functional submission teams and successful regulatory submissions
Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
Excellent communication, leadership, and project management skills
Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless

Job Responsibility

Develop and implement global CMC and device regulatory strategies for assigned program(s)
Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
Identify regulatory risks associated with product development and propose mitigation strategies
Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

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

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Associate Director, Drug Product Manufacturing and Development (Oral)

The Associate Director, Drug Product will support drug product activities with e...

Location

United States , San Diego

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)
Extensive experience with management and oversight of activities at CDMO’s
Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
Strong working knowledge of Excel, Word, PowerPoint
Experience drafting CMC documents for regulatory filings
Experience using quality systems such as Veeva to author and approve documents
Excellent verbal, written and interpersonal skills
Innovative team-player capable of working cross-functionally to achieve program goals
Ability to travel up to 20% (domestic and international)
Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field

Job Responsibility

Contribute to the selection, engagement, and management of CDMO’s, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria
Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
Review master batch records and executed batch records to ensure product quality
Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera’s quality group
Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness
Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Senior Director, Drug Substance Development and Manufacturing

Lead and oversee all outsourced drug substance manufacturing operations. Reporti...

Location

United States , Waltham; San Diego

Salary:

210000.00 - 270000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing
Deep expertise in both synthetic and recombinant manufacturing approaches
Hands-on experience with the synthesis and manufacturing of peptides is mandatory
Demonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activities
Sound technical skills in applying scientific principles to complex process design, implementation, and successful technology transfer
Solid knowledge of current Good Manufacturing Practices (cGMPs), Quality systems, and global regulatory requirements (e.g., FDA, EMA)
Proven experience with the drafting, review, and authoring of CMC sections for major global regulatory submissions (e.g., IND, NDA, MAA)
Exceptional solution-based critical thinking skills and the ability to operate with a keen sense of urgency and an entrepreneurial spirit
Demonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issues
Ability to strategically contribute to and manage multiple concurrent projects

Job Responsibility

Direct and lead all process development, scale-up, technology transfer, and validation activities for peptide drug substance manufacturing across all Contract Development and Manufacturing Organizations (CDMOs)
Establish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO network
Define the long-term vision for manufacturing by maintaining a deep knowledge of industry trends, technological advancements, green manufacturing processes, and emerging regulatory changes
Manage and enforce CDMO performance against key project timelines, deliverables, and costs
Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners
Oversee budget planning and forecasting for all outsourced drug substance manufacturing activities
Serve as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs
Oversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA)
Direct the preparation and final authorship of high-quality technical reports, executive summaries, and presentations to effectively communicate results and progress to internal leadership and external stakeholders

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Director, CMC Regulatory Affairs

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 10, 2026

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