- Primary responsibilities include planning, preparation, submission and maintenance of IND’s and CTA’s in USA and EU, and liaison role with CRO’s
- Regulatory affairs activities and deliverables include providing strategic, technical and regulatory input for Oxular’s medical products (drugs products and medical devices), CMC for the development of human medicinal products, GMP manufacturing of both drug products and devices, clinical development, regulatory filings.
- Technical authorship of Clinical Trial Applications, INDs, Marketing Authorisation Applications, New Drug Applications, Scientific Advice and Meeting Briefing Documents
- Planning and execution of launch and commercialization activities and support for commercial/marketing, market access, PV, compliance and quality/supply chain throughout the product lifecycle
- Filing and review of US-FDA/EMA/NCA applications for the New drug products and Medical devices
- 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.
- Collaborate across functions and find the balance between quality/regulatory standards and start-up agility
Education & experience
- MS, PhD in Pharmacy, Chemistry, Biochemistry, or Pharmacology, or a related scientific discipline or equivalent combined education and experience.
- 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.
- Experience in preparation of IND and CTA applications for drug products required, preferably experience weighted toward US-FDA. Experience in writing Technical Files and 510(k) or PMA applications for medical devices is an advantage.
- Clinical development and/or pharmaceutical industries experience required.
- Approximately ten years of regulatory affairs experience with both drug products and medical devices, with experience in ophthalmology as a preference. Experience in clinical study design and with combination drug-device products is an advantage.
- 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 regulatory support of drug development, including clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development. Preference for candidates with significant experience in drug development for the United States and Europe. Exposure to development of new chemical entities is an advantage.