Career Opportunities 

Our client is a privately held biopharmaceutical company focused on building a robust pipeline by advancing its proprietary late stage photodynamic therapy product. The Head of Regulatory Affairs will be responsible for managing regulatory submissions and conducting internal and external regulatory/clinical compliance audits in relation to FDA regulations. This role will be immersed in the development and implementation initiatives aimed at enhancing the commercial success of the company. He/She will represent the company at meetings with FDA or other government agencies and provide regulatory input into the selection of strategic product development targets for the Corporation.

  • Responsible and accountable for the strategic direction, leadership, growth, tactical and operational success of the company’s regulatory program and will act as Head of Worldwide Regulatory Affairs for the Company.
  • Develop and implement Global (primary focus on US and EU) regulatory strategies for the company and serve as the lead contact to the FDA and other health authorities.
  • Lead the preparation and submission of worldwide regulatory applications to the FDA / other health authorities (ex-US) supporting clinical development programs and marketing application filings.
  • Create, organize, review and lead the preparation of all pre-filing and pre-approval submissions in accordance with FDA regulations.
  • Filings/Reports include, but are not limited to, IND, CTA, BLA, MAA, annual reports, meeting packages, and other submissions/regulatory communications as required.
  • Review and develop a plan for existing and new draft regulatory guidelines, impact of regulatory trends, risk, as well as compliance requirements. Provide regulatory intelligence and advice on relevant new and existing regulatory strategies.
  • Lead and manage both internal and external Regulatory Affairs teams / vendors. Review current Regulatory Affairs structure and resources, determine and remedy any existing gaps, and develop regulatory SOPs for the company.


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Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
565 E. Swedesford Rd.
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Wayne, PA 19087

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