New · posted Oct 15
PTC Therapeutics · Pharmaceuticals
Associate Director, Regulatory Affairs - CMC
- United States
- On-site
- Full-time
- Director
Open until filled
The role
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.
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
What you need
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.
- 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 20% travel
What you'll do
- 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
Pay and benefits
$169,100 – $212,800 a year
Employer providedExpected 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.
Short- and long-term incentives
Medical insurance
Dental insurance
Vision insurance
Retirement savings plan
Where you'll work
United StatesOn-siteOpen in Maps (opens in a new tab)
Equal opportunity, accessibility and legal noticesPTC Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $169,100 | — | $212,800 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: PTC Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not PTC Therapeutics's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Regulatory submissions8
- Documentation and SOPs7
- GMP and compliance3
- Lab testing and methods2
- Investigations and CAPA2
- Quality systems and risk2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
PTC Therapeutics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 2
- Locations
More roles at PTC Therapeutics
- View role
Senior Manager, Global Clinical Regulatory Lead
Warren, NJ · HybridManagerPharmaceuticals$130K–$165K
Similar Regulatory CMC roles elsewhere
- View role
Senior Director, Regulatory Affairs CMC
Madrigal PharmaceuticalsWaltham, MA +1 more · HybridDirectorPharmaceuticals$259K–$293K
- View role
Director, Regulatory Affairs CMC
Madrigal PharmaceuticalsWaltham, MA · HybridDirectorPharmaceuticals$207K–$253K
- View role
Senior Director, CMC Regulatory
KardiganSouth San Francisco, CA · HybridDirectorPharmaceuticals$248K
- View role
Senior Director, CMC Regulatory
KardiganPrinceton, NJ · HybridDirectorPharmaceuticals$241K
Associate Director, Regulatory Affairs - CMC at PTC Therapeutics
Open until filled. $169K–$213K a year, employer provided.