CAREERS

Director/Sr. Director, Regulatory Affairs

Reports To: Vice President, Global Regulatory Affairs

Location: Malvern, PA / Hybrid

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Job Description:

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The Director/Senior Director of Regulatory Affairs will lead and execute global regulatory strategies to advance and ultimately register asset/s with acceleration of timelines and regulatory de-risking top of mind. The successful candidate will be part of the Regulatory Affairs team with the ability to work and deliver for assigned projects independently, with appropriate oversight. The ideal candidate will be based in Malvern, PA and will be able to work in a hybrid environment.

 

Essential Duties and Responsibilities

• Develop, lead, and execute global regulatory strategies to advance and register assets under development (e.g., new INDs, CTA, expedited pathway submissions, pediatric strategy, etc.).

• Partner with drug development teams, clinical, CMC, and broader organization to ensure execution of regulatory strategies.

• Serve as the primary interface with regulatory agencies (US and ex-US) for submissions, communications, and health authority interactions.

• Identify short and long-term program requirements and assemble project updates/analysis for senior leadership.

• Ensure effective stakeholder management and communication related to regulatory activities.

• Oversee and manage open INDs, CTA/CTR, and outside US (OUS) applications for ongoing trials.

• Manage periodic reporting requirements, regulatory documentation, and trackers.

• Oversee and lead the preparation of regulatory dossiers and author briefing packages.

• Track post-approval commitments, monitor, and report key priorities and obligations.

• Stay updated on and share learnings related to relevant science and competitive landscape.

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Qualifications

• Bachelor's degree in life science; advanced degree preferred (MS, PharmD, PhD).

• 7+ years of pharmaceutical/biotechnology industry experience, including 5 years in regulatory affairs.

• Knowledge of regulatory requirements and processes in the US, EU, and globally; experience in biologics and multiple product type are a plus.

• Experience interacting with regulatory agencies and managing clinical trial applications in various geographies.

• Strong leadership, project management, organizational, and interpersonal skills.

• Ability to work independently on assigned projects with appropriate oversight.

• Ability to work outside core hours and travel as required (10-15%).