The Director, Regulatory Affairs – CMC (Drugs) is responsible for providing regulatory leadership in Chemistry, Manufacturing and Control (CMC), including: leading the CMC regulatory strategy development and implementation; direct and manage regulatory CMC activities and dossier content for global health authorities within timelines and in accordance with global regulatory expectations and requirements.
- Leads and manages the development and preparation of CMC-related submission documents and ensures they meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but not limited to, new drug marketing applications (eg NDA, MAA, NDS, etc), electronic Common Technical Documents (eCTDs), investigational new drug applications (eg INDs, CTAs), briefing documents, response to queries, Orphan Drug Applications, and annual reports.
- Provides effective Regulatory CMC leadership and representation for clinical and commercial stage pharmaceutical products and acts as a key player in interactions with regulatory agencies on CMC related topics, in collaboration of the global regulatory teams.
- Effectively interprets and applies regulatory guidance and provides regulatory recommendations and solutions to key stakeholders.
- Drives alignment building of regulatory CMC strategy within RA department and other functions. Effectively communicate regulatory strategy in a cohesive RA voice to the stakeholders.
- Actively collaborates with development teams and Quality to develop and execute robust regulatory strategies and risk mitigation for product development, registration.
- Remains current on CMC regulatory intelligence including guidelines, compendial requirements, and regulatory trends.
Minimum level of education and years of relevant work experience.
- Bachelor’s degree in a scientific discipline. A minimum of 8 years progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology or related environment (including a minimum of 5 years in Regulatory CMC role(s)).
Special knowledge or skills needed and/or licenses or certificates required.
- Excellent working knowledge of the ICH region regulations for drugs.
- Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
- Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, briefing documents, and response to agency queries.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
Special knowledge or skills and/or licenses or certificates preferred.
- Advance academic degree (Masters or PhD).
- Regulatory experience in non-CMC related matters.
- Regulatory experience in supporting development and registration in ex-ICH regions