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Director, Regulatory Affairs

Director, Regulatory Affairs

Location: Malvern, PA/ San Diego, CA/ Remote Job

 
Job Purpose:

 

The Director, Regulatory Affairs, will lead and execute global regulatory strategies to advance and ultimately register the asset/s with acceleration of timelines and regulatory de-risking at top of mind. The successful candidate will be part of the Regulatory Affairs team with the ability to work independently with appropriate direction. They will be accountable for partnering with drug development teams, clinical, CMC and the broader organization to ensure execution of regulatory strategies. The selected candidate will be a primary interface with regulatory agencies both in the US and ex-US, with responsibility for regulatory agency submissions, communications, health authority (HA) interactions including development of materials, and preparation for meetings as necessary.

Responsibilities:

  • Work across all aspects of Regulatory Affairs within the development pipeline to include CMC, clinical and non-clinical regulatory strategy, and activity.

  • Develop and execute strategic regulatory initiatives including new IND, CTA, and OUS submissions to advance indications and assets.

  • Oversee and manage open INDs, CTA/CTR and OUS applications for ongoing trials either internally or in conjunction with contract research organizations (CROs) as necessary.

  • Serve as primary liaison between Uniquity and health authorities for all assigned projects.

  • Oversee and lead the preparation of effective and persuasive presentations, negotiations, and submissions of regulatory dossiers to regulatory authorities.

  • Support any appropriate/relevant business development and due diligence efforts if and as they arise. Accomplishments: Success in this role will accomplish:

  • Improving Uniquity’s overall drug development process

  • Executing the regulatory requirements in the US, EU and certain Asia countries

  • Designing/executing improved regulatory pathways and strategies.

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