{"id":1460132,"url":"https://alion.io/job/crisprtx-associate-director-regulatory-affairs-cmc","title":"Associate Director, Regulatory Affairs CMC","company":{"id":1892348,"name":"crisprtx","domain":"crisprtx.com","url":"https://alion.io/company/crisprtx","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":63,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":165000,"max":180000,"currency":"USD","period":"year","gross":null,"usd_annual":180000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Exa","optional":false}],"status":"live","first_seen_at":"2026-06-16T00:00:00Z","employer_posted_date":"2026-06-16","last_verified_at":"2026-10-29T02:48:11Z","board_verified":true,"closed_at":null,"days_open":135,"trust":{"level":"ok","repost_count":0,"flags":[],"days_open":135},"description":"Job Description:\nCompany Overview\nFounded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY®(exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependentbeta thalassemia. CRISPRTherapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics hasestablished strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug,Switzerland, with its wholly-owned U.S. subsidiary, CRISPRTherapeutics, Inc., and R&D operations based in Boston, Massachusetts and SanFrancisco,California.\nPosition Summary\nThis position is a key leadership role for the development of the Zugo-cel CAR-T franchise at CRISPR. Reporting to the Head of Regulatory Affairs, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strategies where little precedent exists. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.\nResponsibilities\nAct as Regulatory CMC Lead for assigned programs providing strategic guidance to development teams on complex Regulatory CMC topics.\nIn close collaboration with the CMC team, plan, prepare, and submit high-quality CMC related applications including INDs and CTAs globally.\nCommunicate with regulatory agencies on CMC topics, as appropriate.\nLead and support Health Authority meeting strategy and preparation for CMC topics.\nAssess proposed technical changes and provide strategic regulatory guidance to enable global implementation.\nDrive adherence to CMC regulatory guidelines relevant for the development of transformative gene-based medicines.\nParticipate in regulatory intelligence activities as they pertain to global CMC regulations and guidance and provide regulatory advice to program teams.\nBuild and maintain strong relationships with internal and external stakeholders.\nMinimum Qualifications\nBachelor’s degree required in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering.\nPrior regulatory CMC experience with a demonstrated track record of significant accomplishments:Associate Director:12+ Years of relevant experience with a bachelor's degree\n10+ Years of relevant experience with an advanced degree \n\nMust have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics).\nCurrent knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these principles to Regulatory CMC strategies for novel products.\nWorking knowledge of eCTD requirements for submission to US and ex-US regulatory agencies for IND, IMPD, CTA, BLA, NDA, MAA.\nExceptional ability to communicate verbally and in writing, and superb organizational skills required.\nAbility to manage multiple priorities within a dynamic organizational and team structure.\nPreferred Qualifications\nA PhD in biochemistry, chemistry, biology, or related pharmaceutical fields including chemical engineering is highly desirable.\nLate phase IND/CTA/GMO submission authoring, and understanding of FDA/EMA requirements for corresponding dossier development\nCompetencies\nCollaborative - Openness, One Team\nUndaunted - Fearless, Can-do attitude\nResults Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.\nEntrepreneurial Spirit - Proactive. Ownership mindset.\nCRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.\nAssociate Director, Regulatory Affairs CMC: Base pay range of $165,000 to $180,000+ bonus, equity and benefits\nThe range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.\nCRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.\nTo view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy","description_format":"text","description_chars":5790,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Cell & Gene Therapy"],"lifecycle":[{"event":"open","at":"2026-09-29T11:54:35Z"}],"visa":[],"liveness":{"score":21,"band":"cold","label":"Long shot","p_open":1,"p_active":0.74,"p_room":0.28,"age_days":135,"expected_fill_days":63,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":180000,"is_top_pay":false},"html_url":"https://alion.io/job/crisprtx-associate-director-regulatory-affairs-cmc","json_url":"https://alion.io/job/crisprtx-associate-director-regulatory-affairs-cmc.json","meta":{"generated_at":"2026-10-29T12:13:59Z","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":18294,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":1892348},"rest":"https://alion.io/mcp/rest/get_company?id=1892348"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcrisprtx-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%2Fcrisprtx-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%2Fcrisprtx-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/crisprtx-associate-director-regulatory-affairs-cmc\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcrisprtx-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":1460132}},{"tool":"search_jobs","arguments":{"company":"crisprtx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1460132},"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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