Director of Regulatory Affairs

Hobson Prior has partnered with a clinical-stage retinal therapeutics organisation who are looking for a Director of Regulatory Affairs to join them on a permanent basis in either New York or Boston. Our client is developing technology to transform the treatment of retinal disease, giving patients life-changing solutions to their unmet needs.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Co-operate across functions and find the balance between quality/regulatory standards and start-up agility.
• Communicate and liaise with regulatory agencies as needed to support the development of the regulatory submissions and Educate internal stakeholders on current regulatory trends and expectations.
• To plan and execute launch and commercialization activities and support for commercial/marketing, market access, PV, compliance and quality/supply chain throughout the product lifecycle.
• CMC for the development of human medicinal products, GMP manufacturing of both drug products and devices, clinical development, regulatory filings.
• Filing and review of US-FDA/EMA/NCA applications for the New drug products and Medical devices.
• Technical authorship of Clinical Trial Applications, INDs, Marketing Authorisation Applications, New Drug Applications, Scientific Advice and Meeting Briefing Documents.

Requirements:

• In-depth knowledge of 21 CFR 210/211, Eudralex EU GMP, 21 CFR part 820, 21 CFR part 312, 21 CFR part 316, ISO 13485, MDR and other international regulations and standards for both drug products and medical devices.
• MS, PhD in Pharmacy, Chemistry, Biochemistry, or Pharmacology, or a related scientific discipline or equivalent combined education and experience.
• You will have around 10 years of regulatory affairs experience with both drug products and medical devices, with experience in ophthalmology as a preference.
• Experience in preparation of IND and CTA applications for drug products required, preferably experience weighted toward US-FDA.
• Clinical development and/or pharmaceutical industries experience required.
• Experience in interactions with health authorities and hands-on experience managing regulatory programs from product development through clinical development and the approval process.
• Experience in support of drug development, including clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.