Associate Director, Regulatory Affairs - CMC
PTC Therapeutics, Inc.
August 06, 2026
Remote friendly (New Jersey, United States)
United States
Corporate Functions
Job Description Summary
The Associate Director, Regulatory Affairs – CMC will lead global regulatory CMC strategy for product development and registration and prepare CMC dossiers for primarily small-molecule regulatory submissions (INDs and NDAs) per global regulatory expectations and requirements.
Responsibilities
- Lead and manage development and preparation of CMC-related submission documents to meet regulatory standards and enable approval on first review cycle (e.g., NDA/MAA/NDS, eCTDs, INDs/CTAs, briefing documents, responses to queries, Orphan Drug Applications, annual reports).
- Lead global post-approval CMC regulatory strategy for commercial products, including lifecycle changes (manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, analytical method changes) to ensure supply continuity and align to regional requirements.
- Collaborate with Regulatory Affairs to develop global CMC regulatory strategy and risk mitigation.
- Manage or assist with regulatory agency interactions.
- Interpret and apply regulatory guidance; provide recommendations and solutions to cross-functional teams.
- Work with CMC Writing, Regulatory Operations, and Submission Project management to improve internal processes for CMC document writing/review/approval and comment reconciliation.
- Support regulatory CMC compliance best practices (change controls, post-marketing commitments, product complaints, regulatory inspections).
- Stay current on CMC regulatory intelligence (guidelines and compendial requirements).
Qualifications / Skills
- Bachelor’s degree in a scientific discipline; 7–8 years Regulatory Affairs and/or CMC technical writing experience (pharma/biotech or related). Advanced degree a plus.
- Technical knowledge in small molecules; hands-on experience in pharmaceutical development/registration and post-approval lifecycle management in a global environment.
- GMP experience; firm understanding of industry regulations/best practices.
- Strong working knowledge of ICH regulations for small molecules.
- Experience preparing IND/CTA, NDA/MAA, NDS, briefing documents, and responses to agency queries.
- Ability to influence without direct authority; strong collaboration.
- Excellent verbal/written communication; independent and matrixed team collaboration.
- Analytical/problem-solving, planning, organization, time management; adaptable to changing priorities.
- Proficient in Microsoft Office.
- (Preferred) Masters/PhD; regulatory experience in non-CMC matters; experience in ex-ICH regions.
Travel: Up to 10%.
Benefits/Compensation (if eligible): Short- and long-term incentives; medical, dental, vision, and retirement savings plans.
The Associate Director, Regulatory Affairs – CMC will lead global regulatory CMC strategy for product development and registration and prepare CMC dossiers for primarily small-molecule regulatory submissions (INDs and NDAs) per global regulatory expectations and requirements.
Responsibilities
- Lead and manage development and preparation of CMC-related submission documents to meet regulatory standards and enable approval on first review cycle (e.g., NDA/MAA/NDS, eCTDs, INDs/CTAs, briefing documents, responses to queries, Orphan Drug Applications, annual reports).
- Lead global post-approval CMC regulatory strategy for commercial products, including lifecycle changes (manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, analytical method changes) to ensure supply continuity and align to regional requirements.
- Collaborate with Regulatory Affairs to develop global CMC regulatory strategy and risk mitigation.
- Manage or assist with regulatory agency interactions.
- Interpret and apply regulatory guidance; provide recommendations and solutions to cross-functional teams.
- Work with CMC Writing, Regulatory Operations, and Submission Project management to improve internal processes for CMC document writing/review/approval and comment reconciliation.
- Support regulatory CMC compliance best practices (change controls, post-marketing commitments, product complaints, regulatory inspections).
- Stay current on CMC regulatory intelligence (guidelines and compendial requirements).
Qualifications / Skills
- Bachelor’s degree in a scientific discipline; 7–8 years Regulatory Affairs and/or CMC technical writing experience (pharma/biotech or related). Advanced degree a plus.
- Technical knowledge in small molecules; hands-on experience in pharmaceutical development/registration and post-approval lifecycle management in a global environment.
- GMP experience; firm understanding of industry regulations/best practices.
- Strong working knowledge of ICH regulations for small molecules.
- Experience preparing IND/CTA, NDA/MAA, NDS, briefing documents, and responses to agency queries.
- Ability to influence without direct authority; strong collaboration.
- Excellent verbal/written communication; independent and matrixed team collaboration.
- Analytical/problem-solving, planning, organization, time management; adaptable to changing priorities.
- Proficient in Microsoft Office.
- (Preferred) Masters/PhD; regulatory experience in non-CMC matters; experience in ex-ICH regions.
Travel: Up to 10%.
Benefits/Compensation (if eligible): Short- and long-term incentives; medical, dental, vision, and retirement savings plans.