Director, Global Regulatory Affairs (Submission Project Management) Job at Kailera Therapeutics (Waltham)

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
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
Provide regulatory due diligence as required
Supervise and mentor direct reports

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

New

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
8+ years of pharmaceutical industry experience
6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
Experience in rare diseases, especially rare hematological disorders, preferred
Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
Ability to advise on applicable regulations and guidance documents
Understands and interprets scientific data as it relates to regulatory requirements and strategy
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy

Job Responsibility

Developing and executing innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders
Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects
Represent Regulatory Affairs at project team meetings
Collaborate across technical functions to create innovative regulatory strategies and pragmatic solutions
Effectively communicate regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders
Proactively anticipate regulatory risks and develop mitigation strategies
Accountable for all Regulatory Agency submissions and approvals of project(s) of responsibility
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings
Oversee vendor responsibility for regulatory activities and submissions
Participate in or lead departmental and cross-functional taskforces and initiatives

Fulltime

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 of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

Sweden , Greater Malmö Metropolitan Area

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
8+ years of pharmaceutical industry experience
6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
Experience in rare diseases, especially rare hematological disorders, preferred
Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
Ability to advise on applicable regulations and guidance documents
Understands and interprets scientific data as it relates to regulatory requirements and strategy
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy

Job Responsibility

Develop and execute innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders
Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects
Keep abreast of new developments in regulatory science and maintain oversight on the evolving regulatory landscape and advancing innovations
Understand and interpret scientific data as it relates to regulatory requirements and strategy
Represent Regulatory Affairs at project team meetings
Collaborate across technical functions to create innovative regulatory strategies and pragmatic solutions
Effectively communicate regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders
Proactively anticipate regulatory risks and develop mitigation strategies
Be accountable for all Regulatory Agency submissions and approvals, overseeing outsourced vendors and/or internal team members
Be the direct point of contact with health authorities, lead and manage Regulatory Agency meetings

Fulltime