Job Description Summary:
Associate Director, Regulatory Affairs – CMC (Biologics) is responsible for leading regulatory CMC strategy and for preparation of CMC dossier of biologics regulatory submissions according to global regulatory expectations and requirements.
This position works cross-functionally with Regulatory Affairs, Technical Operations, and Quality to facilitate the completion of regulatory filing documentation in accordance with company timelines.
This position ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriateJob Description:
- Leads and manages the preparation and technical writing of CMC-related submission documents for biological products in collaboration with Technical Operations, Quality, and Regulatory Affairs to ensure they are organized, logical, and 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 BLA, 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.
- Collaborates with Regulatory Affairs Team to develop robust regulatory CMC strategy and risk mitigation to enable successful regulatory submissions and approvals.
- Manage or assist with regulatory agency interactions.
- Effectively interprets and applies regulatory guidance. Provides regulatory guidance, recommendations and solutions to cross functional teams and key stakeholders.
- Works with Regulatory Operations and Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality ready for the next phases of review or submission.
- Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.
- Remains current on CMC regulatory intelligence including guidelines and compendial requirements
* Minimum level of education and years of relevant work experience.
Bachelor's degree in a scientific discipline. A minimum of 7-8 years Regulatory Affairs and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Technical knowledge in cell and gene therapies with experience in translating to a regulatory document
- Demonstrated, hands-on experience in pharmaceutical development, registration, and post-approval life cycle management in a global environment.
- Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
- Excellent working knowledge of the ICH region regulations for biologics and drugs.
- Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
- Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/BLA/MAA, briefing documents, and response to agency queries.
- Ability to influence without direct authority.
- Demonstrated excellent collaboration skills.
- 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.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Proficiency with Microsoft Office.
*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
* Travel requirements
*Physical requirements (only note if the job requires physical capacity beyond general office work)
Office based position