We are a clinical stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life threatening viral infections. Currently, we are focused on the development of orally available, potent, and selective nucleotide prodrugs for difficult to treat, life-threatening viral infections, including SARS-CoV-2, the virus that causes COVID-19, chronic hepatitis C infection (“HCV”), dengue virus, and respiratory syncytial virus (“RSV”).
The Director, Regulatory CMC will be responsible for developing and delivering innovative regulatory CMC strategies for product development and approval. This is an exciting role for a qualified and motivated individual to manage regulatory CMC activities over several products for the company. The ideal candidate will have strong regulatory CMC experience in the development of small molecule products and have worked on INDs and/or NDAs.
- Oversees the development and implementation of the global regulatory CMC strategy, and acts as the regulatory CMC expert for assigned products.
- Develops the global regulatory CMC strategy for CTA/INDs, NDA/MAAs, Health Authority meetings, etc.
- Collaborates on the development and/or optimization of product development strategy to be consistent with regulatory requirements.
- Determines and gains alignment with the CMC team on the required content for CMC dossiers and timelines.
- Supports dossier preparation, review and publishing processes in line with project timelines to deliver high-quality submissions.
- Interacts with regulatory authorities and external partners to address CMC regulatory strategy, milestone meetings, queries and regulatory actions.
- Maintains a high-level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.
- Represents regulatory CMC in industry association teams to influence policy and practice for small molecule antiviral programs.
- Collaborates on authoring Standard Operating Procedures and developing internal processes for the regulatory affairs department.
- Manages CMC-related Health Authority liaison and communication.
- Anticipates the impact of the changing regulatory environment on development plans and registration strategy. Develops and implements strategies to proactively influence/address these changes.
- Degree in a scientific/technical discipline (BS, MS, PhD or PharmD) with a minimum of 10 years’ pharmaceutical drug development experience and 5 years’ hands-on regulatory CMC experience.
- Proven expertise / experience with developing global regulatory CMC strategies for small molecule products, leading regulatory submissions and health authority interactions.
- Must have worked on small molecule INDs, CTAs, NDAs, and/or MAAs.
- Sound understanding of ICH and major markets' regulations on small molecule development.
- Proven track record in new chemical entity and line extension regulatory filings, approvals, and strategic planning.
- Basic computer skills (MS Office, MS Teams, MS Excel, MS PowerPoint and Adobe Acrobat).
- Experience supporting and conducting due diligence activities.
- Familiarity/understanding of global regulatory agencies (e.g. US FDA, EMA, MHRA, Health Canada).
- Ability to communicate clearly and concisely with senior management and regulatory authorities.
- Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.
- Excellent and proven negotiation skills.
- Ability to effectively work in a team environment and develop peer relationships.
- Strong interpersonal and organizational skills.
- Excellent writing and verbal communication skills.