Associate Director, Regulatory Affairs

Candel Therapeutics•Needham, MA

5d•$160,000 - $200,000•Remote

About The Position

The Associate Director, Regulatory Affairs will serve as a regulatory strategist supporting one or more development programs across the product lifecycle, from clinical development through marketing authorization and post-approval maintenance. This is a global role with primary responsibility for developing and executing regulatory strategies that enable efficient multinational clinical development and timely marketing approvals across major markets, including the US, EU, UK, Japan, and other regions. The successful candidate will bring substantial experience navigating the global regulatory landscape for biologics, with demonstrated expertise in late-stage clinical development and ex-US health authority interactions. The ideal candidate will have familiarity with oncology product development as well as the unique regulatory considerations for advanced therapy medicinal products (ATMPs).

Requirements

Bachelor’s degree
8+ years of progressive experience within the biopharmaceutical industry, with a minimum of 5 years focused in regulatory and a substantial portion in global or international regulatory roles preferred.
Direct experience supporting multinational late-stage (Phase II/III or pivotal) clinical trials, including multi-country CTA submissions and management of region-specific regulatory requirements.
Demonstrated experience working with ex-US health authorities, including EMA (centralized procedure, Scientific Advice, CAT/CHMP interactions), MHRA, Health Canada, PMDA, TGA, or other major regulatory agencies.
Experience with biologics development, including familiarity with the regulatory framework for biological products
Experience working with CROs and regulatory consultants to manage multi-country regulatory filings and health authority interactions
Track record of authoring or leading the preparation of major regulatory submissions (INDs/CTAs, marketing applications, or significant supplements/variations).
Strong working knowledge of ICH guidelines, FDA regulations, EU regulatory framework (Regulation 536/2014, centralized/decentralized procedures), and eCTD format.
Applicants must be legally authorized to work in the United States at the time of hire and throughout employment.
Core working hours will be based in U.S. Eastern Time.
The successful candidate must have flexibility to participate in meetings outside of core hours as needed to support collaboration with international teams across Europe and Asia.

Nice To Haves

RAC certification is a plus
Direct experience with the preparation and submission of a Marketing Autorisation Application (MAA) through the EMA centralized procudure, including interactions with the rapporteur/co-rapporteur, responses to Day 120/180 questions, and oral explanations.
Experience with gene therapy, cell therapy, or other ATMP products, including familiarity with EMA’s CAT (Committee for Advanced Therapies) review pathway, ATMP classification, and the distinct regulatory considerations for these modalities (e.g., long-term follow-up requirements, conditional marketing authorization, hospital exemption frameworks).
Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely.
Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders.
Strategic thinker with strong problem-solving and decision-making abilities.
Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment.
Proven collaboration with Clinical, Biostatistics, Regulatory, Safety, Research and CMC; consistent milestone and risk tracking with timely issue resolution.

Responsibilities

Develop, communicate, and execute global regulatory strategies for assigned programs, ensuring alignment across US (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and other target markets.
Lead the preparation of global regulatory submission plans, including sequencing and interdependencies across INDs/CTAs, Orphan Drug Designations, Pediatric Study Plans/PIPs, Breakthrough Therapy / PRIME / Innovation Passport designations, and marketing applications.
Provide regulatory input to clinical development plans, protocol design, and study endpoints, ensuring alignment with health authority expectations and regional requirements.
Advise on regulatory implications of evolving clinical data, including benefit-risk assessment, labeling strategy, and indication scope.
Develop and maintain regulatory risk assessments and mitigation strategies for assigned programs.
Develop relationships with expert regional consultants/services for advice and local legal and health authority representation
Serve as a primary Candel regulatory point of contact via regional consultants/services for health authority interactions across multiple regions, including EMA (Scientific Advice, CHMP/CAT interactions), MHRA, PMDA, and other national competent authorities.
Lead preparation of briefing documents, meeting requests, and regulatory correspondence for health authority meetings by managing activities of outside consultants/services.
Oversee preparation and submission of CTAs across multiple countries, in conjunction with a CROs as applicable, ensuring compliance with regional requirements and timely site activations for multinational clinical trials.
Lead the preparation of ex-US marketing applications (MAAs), including coordination of Module 1 regional requirements and assist in the development of core dossier Modules 2–5.
Ensure consistency and quality of regulatory documents across submissions, maintaining a coherent global regulatory narrative.
Manage regulatory aspects of protocol amendments, safety reporting obligations, and annual reporting requirements across active INDs/CTAs globally.
Partner with Clinical, CMC, Quality, Research, and Commercial teams to ensure regulatory alignment across all functional deliverables.
Collaborate with CMC regulatory colleagues on integrated regulatory strategy, particularly for programs involving novel manufacturing platforms or ATMP-specific regulatory pathways.
Monitor and interpret evolving regulatory guidance, legislation, and policy across major markets, with particular attention to oncology/immuno-oncology regulatory trends, ATMP/gene therapy frameworks, and expedited development pathways.