{"id":1549539,"url":"https://alion.io/job/ptcbio-associate-director-regulatory-affairs-cmc","title":"Associate Director, Regulatory Affairs - CMC","company":{"id":2004095,"name":"PTC Therapeutics","domain":"ptcbio.com","url":"https://alion.io/company/ptcbio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":169100,"max":212800,"currency":"USD","period":"year","gross":null,"usd_annual":212800},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-14T00:00:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-11-05T06:41:20Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"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.\nAt 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.\nVisit our website to learn more about our company and culture!\nSite: www.ptcbio.com\nJob Description Summary:\nThe 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.\nThis position ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.\nJob Description:\nResponsibilities:\nLeads 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.\nLeads 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.\nCollaborates 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.\nManage or assist with regulatory agency interactions.\nEffectively interprets and applies regulatory guidance. Provides regulatory guidance, recommendations and solutions to cross functional teams and key stakeholders.\nWorks 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.\nSupports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.\nRemains current on CMC regulatory intelligence including guidelines and compendial requirements \nQualifications:\nBachelor’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.\nTechnical knowledge in small molecules with experience in translating to a regulatory document\nDemonstrated, hands-on experience in pharmaceutical development, registration, and post-approval life cycle management in a global environment.\nPrior experience within a GMP environment with a firm understanding of industry regulations and best practices\nExcellent working knowledge of the ICH region regulations for small molecule drugs.\nKnowledge of global regulatory guidance as they relate to the overall global regulatory strategy.\nAbility to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.\nDemonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, NDS, briefing documents, and response to agency queries.\nAbility to influence without direct authority.\nDemonstrated excellent collaboration skills.\nExcellent verbal and written communication and skills.\nAbility to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.\nAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.\nExcellent planning, organization and time management skills including the ability to support and prioritize multiple projects.\nProficiency with Microsoft Office.\nAdvance academic degree (Masters or PhD).\nRegulatory experience in non-CMC related matters.\nRegulatory experience in supporting development and registration in ex-ICH regions\nTravel requirements- Up to 20% travel\nExpected Base Salary Range:\n$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.\nIn 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.\nEEO Statement:\nPTC 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.\nClick here to return to the careers page","description_format":"text","description_chars":6068,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-30T23:49:22Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 6 · green card filings: 1","filings_12m":6,"filings_prev_12m":9,"green_card_filings_12m":1,"median_offered_wage_usd":106786,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":25,"band":"fade","label":"Fading","p_open":1,"p_active":0.713,"p_room":0.35,"age_days":52,"expected_fill_days":24,"reasons":["conf:12","win:tail"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":212800,"is_top_pay":false},"html_url":"https://alion.io/job/ptcbio-associate-director-regulatory-affairs-cmc","json_url":"https://alion.io/job/ptcbio-associate-director-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-11-05T09:59:11Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":12792,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2004095},"rest":"https://alion.io/mcp/rest/get_company?id=2004095"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fptcbio-associate-director-regulatory-affairs-cmc"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fptcbio-associate-director-regulatory-affairs-cmc"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fptcbio-associate-director-regulatory-affairs-cmc"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/ptcbio-associate-director-regulatory-affairs-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fptcbio-associate-director-regulatory-affairs-cmc"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1549539}},{"tool":"search_jobs","arguments":{"company":"ptcbio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1549539},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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