The Manager, CMC Regulatory Affairs is the company’s regulatory representative, responsible for designing and implementing a regulatory strategy under the guidance of regulatory advisor. The manager is accountable for adherence to relevant regulatory requirements and company SOPs. S/he will contribute and implement industry best practices and provide hands-on management of technical and operational aspects related to regulatory activities ensuring that pharmaceutical products are consistently effective, safe and of high quality. This role coordinates, supports, and assists all aspects of complex, cross-functional technology transfer or process scale-up projects, from original concept through the final implementation on the shop floor, ensuring governance process adherence, project continuity, and stakeholder management. The incumbent develops timelines and risk assessments and is responsible for performance against these parameters; actively monitors and reports on project status, risks and decisions required and highlights assumptions and unknowns to ensure full transparency.
- Develop, present and implement a comprehensive regulatory strategy per product
- Plan, organize and prepare regulatory filings for submissions to regulatory agencies globally as required (e.g., IND, ANDA etc)
- Contribute regulatory input/guidance on product development plans
- Establish appropriate risk-based solutions that account for regulatory requirements and develop alternative courses of action, including anticipation of regulatory responses through contingency planning
- Collaborate with Quality on vendor qualification, corrective and preventive action system, nonconforming materials, calibration program and document control
- Works closely with manufacturing to provide regulatory support to manufacturing operations and product registrations
- Develop, implement and track relevant KPIs to drive performance improvements
- Participate in FDA and other 3rd party audits as appropriate
- Establish, organize and oversee the maintenance of regulatory records and files
Minimum Master’s degree in a scientific discipline (e.g., Life Science, Pharmacy etc)
- Minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology or contract research organization (CRO).
- Hands-on experience in all phases of regulatory submissions relating to FDA and other national health authorities.
Knowledge, Skills and Abilities:
- Mastery knowledge of FDA regulatory guidelines and standards required to ensure for CMC development complies with all cGMP, OSHA, and EHS practices and meets evolving regulatory requirements.
- Strong technical acumen; background in Process and Analytical Development, Process Transfer, GMP Manufacturing or related technical experience mandatory
- Strong Project Management experience managing CMC development programs across different projects
- Excellent verbal and written communication
- Ability to work independently and collaboratively, as required, 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.
- Strong results driven personality, high level of enthusiasm and energy
- Leadership and mentoring capabilities and strong interpersonal skills
- Astute attention to detail and accuracy
- Flexibility to acquire additional competencies and skill sets as mandated by the changing needs of the organization
Up to 20% travel