Associate Director Regulatory Affairs Job at EPM Scientific, Boston, MA

MjMwaHpPb084bEo2YldLL1pKZXRqRy9Xa3c9PQ==
  • EPM Scientific
  • Boston, MA

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.

Job Tags

Similar Jobs

Pride Health

Transplant Coordinator Job at Pride Health

 ...Job Description Job title : Associate Transplant Coordinator Job location : New York, NY 10032 Shift : M-F 9a-5p Pay : $28-$31/hr Contract : 12 wk assignment, possible extension Skills: Working w/ kidney transplant pts. HS diploma/GED (R... 

Burk Agency

Remote Life Insurance Agent | Client-Focused | Work from Home Job at Burk Agency

 ...and personal impactall from your home office. Join our remote team...  ...protecting middle-income families nationwide. Make an impact, build a legacy, and work from anywhere with a winning team...  ...you love. We are seeking a Life Insurance Agent to join our fast-growing, family... 

Harrison Consulting Solutions

Airport Project Manager Job at Harrison Consulting Solutions

 ...Multi-state designfirm is seeking a Senior Airport Project Manager for their team in St. Louis! Responsibilities: Oversee all aspects of large/complex projects (planning, execution, delivery) Lead/manage team Responsible for determining scope, complexity... 

American Enterprise Institute

Summer Intern: Demographics and Political Economy Job at American Enterprise Institute

 ...internships offer a unique opportunity for undergraduates, graduate students, and recent graduates to gain experience in research, writing,...  ...generally have a GPA of 3.5 or higher from a top-ranking college or university. AEI's internship program runs for 12 weeks,... 

TEKsystems

Bank Teller - North Clearwater Job at TEKsystems

 ...TEKsystems is currently searching for career-driven candidates interested in a Bank Teller opportunity with a Fortune 100 Financial Institution in the North Clearwater, FL 33759 area! Job Description: To provide members and prospective members the full range of...