Regulatory Affairs Manager - CMC, Small Molecule
The Manager, Regulatory Affairs – CMC will play a key role in the regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs in both the pre-approval and post-approval space globally. This position works cross-functionally and serves as a liaison between the Regulatory Affairs team and other PTC departments under supervision of the Regulatory Affairs – CMC management.
The Manager, Regulatory Affairs - CMC ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Develop Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards, are high quality, consistent, complete, and approvable on the first review cycle.
- Establish product specific strategies to ensure successful development of CMC packages to support early development, registration and life cycle management including variations, annual reports, supplements, renewals and responses to questions from health authorities.
- Ensuring compliance with ICH and local regulatory requirements.
- Establish alignment with PTC regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally.
- Review and approve CMC change control documents.
- Effectively communicate comments/recommendations and proactively engage teams to establish solutions to issues.
Minimum level of education and years of relevant work experience.
- Bachelor’s degree in scientific discipline and a minimum of 5 years progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology or related environment (minimum of 3 years in Regulatory CMC or Regulatory Compliance).
- Special knowledge or skills needed and/or licenses or certificates required.
- Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
- Good working knowledge of the FDA, EMEA and ICH regulations and guidance’s for CMC.
- Knowledge of global regulatory guidance’s 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.
- Thorough knowledge of the drug development process, with a focus on the regulatory CMC processes.
- Demonstrated experience in preparing IND and/or NDA submissions.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication and skills.
- Ability to work collaboratively under supervision, 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.
- Travel requirements: 0-10%
- Office-based Position
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.