Talent.com
Associate Director Regulatory Affairs
Associate Director Regulatory AffairsEPM Scientific • Bedford, MA, US
Associate Director Regulatory Affairs

Associate Director Regulatory Affairs

EPM Scientific • Bedford, MA, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description

Job Description

Title : Associate Director of Regulatory Strategy

A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy . This role will lead regulatory strategy for drug-device combination product development.

Key Responsibilities

  • Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
  • Prepare and represent the company in FDA and global Health Authority meetings (Type A / B / C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.
  • Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.
  • Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging / labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
  • Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.
  • Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation.

Qualifications

  • Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.
  • Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
  • Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
  • Familiarity with 505(b)(2) development strategies or innovative delivery platforms.
  • Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.
  • Proven track record of successful interactions with the FDA and / or global regulatory agencies.
  • Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
  • Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.

    • Company Description

    A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.

    Job Responsibilities :

  • \tConducting Post Market Activities and Post Market Surveillance
  • \tManaging Customer and Product Complaint Investigation programs

    • Education and Experience :

  • \t1 YR. of experience in a technical role in the medical device / pharma / biotech industry
  • \tBachelor's degree
  • \tComputer proficiency

    • Company Description

    A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities : \r\n

  • \tConducting Post Market Activities and Post Market Surveillance\r\n
  • \tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience : \r\n
  • \t1 YR. of experience in a technical role in the medical device / pharma / biotech industry\r\n
  • \tBachelor's degree\r\n
  • \tComputer proficiency
    • [job_alerts.create_a_job]

    Associate Director • Bedford, MA, US

    [internal_linking.related_jobs]
    Associate Director, Regulatory Operations

    Associate Director, Regulatory Operations

    Crescent Biopharma, Inc. • Waltham, MA, US
    [job_card.full_time]
    Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Corporate & External Affairs, R&D Portfolio

    Associate Director, Corporate & External Affairs, R&D Portfolio

    CSL Plasma • Waltham, Massachusetts, USA
    [job_card.full_time]
    Associate Director Corporate & External Affairs R&D Portfolio.The Associate Director Corporate and External Affairs R&D Portfolio will lead corporate and external affairs strategy for C...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    SeniorDirector, OncologyPathology Therapeutic Area Lead

    SeniorDirector, OncologyPathology Therapeutic Area Lead

    Neogene Therapeutics • Waltham, MA, United States
    [job_card.full_time]
    Join our dedicated Research & Development team in Biopharmaceuticals R&D asa.SeniorDirector, OncologyPathology Therapeutic Area Lead. You willbe accountable for managing pathology evaluations across...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

    Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

    PharmaEssentia U.S.A. • Burlington, MA, US
    [job_card.full_time]
    It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities.You’ll find that rare opportunity at PharmaEssentia USA.Join us, a...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Analytical Science & Technology (AS&T) – Chemistry & Raw Materials

    Associate Director, Analytical Science & Technology (AS&T) – Chemistry & Raw Materials

    Moderna • Norwood, MA, United States
    [job_card.permanent]
    Moderna is seeking an Associate Director, Analytical Science & Technology (AS&T) – Chemistry & Raw Materials based at their Norwood, MA site. The Associate Director of Analytical Science & Technolog...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Tax Director

    Tax Director

    EisnerAmper • Wellesley, MA, United States
    [job_card.full_time]
    At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact.Whether you're starting out in your career or taking your next step as a seasone...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Conservation Regulatory Aide (PDF)

    Conservation Regulatory Aide (PDF)

    Town of Lexington • Lexington, MA, United States
    [job_card.part_time]
    We are currently accepting applications for the Per Diem position : .Conservation Regulatory Aide (Part-time / Flexible hours). Department of Land Use, Housing & Development.The REQUIRED Town of Lexingt...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regional Director - Finance

    Regional Director - Finance

    Bally's Corporation • Lincoln, RI, United States
    [job_card.full_time]
    Bally's Corporation (NYSE : BALY) is a global casino-entertainment company with a growing omni-channel presence.Bally's owns and operates 19 casinos across 11 states, along with a golf course in New...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Contact Dermatitis Program

    Director, Contact Dermatitis Program

    HealthEcareers - Client • Burlington, MA, USA
    [job_card.full_time]
    Lead our Contact Dermatitis Program!.Lahey Hospital and Medical Center (part of Beth Israel Lahey Health) is seeking a Director to lead and grow our Contact Dermatitis Program.Lead and grow clinica...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director of the Enrollment Management Center

    Associate Director of the Enrollment Management Center

    InsideHigherEd • Lowell, Massachusetts, United States
    [job_card.full_time] +1
    About Middlesex Community College : .Middlesex Community College (MCC), established in 1970, provides access to affordable education to prepare individuals for success and lifelong learning.We promot...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Policy Director

    Regulatory Policy Director

    VirtualVocations • Lowell, Massachusetts, United States
    [job_card.full_time]
    A company is looking for a Regulatory Policy and Intelligence - US Director.Key Responsibilities Provide strategic U.Coordinate the implementation of new U. Required Qualifications Doctorate deg...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Deciphera Pharmaceuticals • Waltham, Massachusetts, USA
    [job_card.full_time]
    We are seeking a dynamic and strategic .Associate Director Regulatory Affairs.The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies t...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Oncology Global Regulatory Affairs Associate Director

    Oncology Global Regulatory Affairs Associate Director

    Women In Bio • Waltham, MA, United States
    [job_card.full_time]
    A global biopharma company is seeking a regulatory professional in Waltham, MA, to lead regional regulatory strategies and collaborate with commercial teams. The ideal candidate has a Bachelor's deg...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Histocompatibility Lab Director

    Histocompatibility Lab Director

    American Red Cross • Dedham, MA, United States
    [job_card.full_time]
    As one of the nation's premier humanitarian organizations, the American Red Cross is dedicated to helping people in need throughout the United States and, in association with other Red Cross networ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director, Regulatory CMC

    Senior Director, Regulatory CMC

    Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
    [job_card.full_time]
    The Senior Director, Regulatory CMC will lead and evolve Apellis's global Chemistry, Manufacturing, and Controls (CMC) strategies to support the company's innovative therapeutic pipeline and market...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Nonclinical Development

    Associate Director, Nonclinical Development

    Ardelyx • Waltham, MA, United States
    [job_card.full_time]
    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Internal Audit

    Director, Internal Audit

    Entegris • Billerica, MA, United States
    [job_card.temporary]
    Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission. Vice President of Internal Audit ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics)

    Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics)

    Oruka Therapeutics • Waltham, MA, United States
    [job_card.full_time]
    Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics).Waltham, Massachusetts, United States.Oruka Therapeutics (Nasdaq : ORKA) is developing novel biologics designed to set a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]