Associate Director, Regulatory Affairs - CMC

PTC Therapeutics, Inc; New Jersey; On-site; USD 169,100 - 212,800; Full time

Benefits offered by this job

Medical, dental, and vision plans

Retirement savings plans

Short- and long-term incentives

Job summary

PTC Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration with Technical Operations and Quality teams. The ideal candidate will have extensive experience in regulatory affairs and a keen understanding of pharmaceutical development.

The position requires strong team collaboration, communication skills, and the ability to prepare regulatory submissions including INDs and NDAs.

Qualifications

• 7-8 years of Regulatory Affairs or CMC technical writing experience in a pharmaceutical environment.
• Experience in preparing regulatory submissions including IND/CTA, NDA/MAA.
• Prior experience within a GMP environment.

Responsibilities

• Lead global regulatory CMC strategy for product development and registration.
• Manage development and preparation of CMC-related submission documents.
• Collaborate on global regulatory CMC strategy and risk mitigation.
• Provide regulatory guidance to cross-functional teams.

Skills

Regulatory submissions preparation

Pharmaceutical development

Technical writing

Influencing skills

Collaboration

Analytical thinking

Communication skills

Microsoft Office proficiency

Education

Bachelor's degree in a scientific discipline

Advanced degree (Masters or PhD)

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture! Site: www.ptcbio.com

The Associate Director, Regulatory Affairs - CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) 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 appropriate.

Responsibilities

• Leads and manages the development and preparation of CMC-related submission documents for small molecule 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 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.
• Leads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale‑up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements.
• Collaborates with Regulatory Affairs Team to develop robust global regulatory CMC strategy and risk mitigation to enable successful regulatory submissions and approvals for drug development and registration.
• 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 CMC Writing, Regulatory Operations, and Submission 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.
• 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

Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment. Advanced degree a plus.

Qualifications

• Technical knowledge in small molecules 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 small molecule drugs.
• Knowledge of global regulatory guidance 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/MAA, NDS, 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.
• 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- Up to 10% travel

Expected Base Salary Range

$169,100 - $212,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short‑ and long‑term incentives. All eligible employees may also enroll in PTC's medical, dental, vision and retirement savings plans.

EEO Statement

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.