CMC Regulatory Strategy Lead - Associate Director
AbbVie
AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for chemistry, manufacturing and controls across products. The role requires collaboration with global teams to prepare regulatory submissions and to represent CMC in agency interactions. The candidate will manage complex regulatory submissions, drive strategy development, and contribute to ongoing improvements in regulatory processes. #J-18808-Ljbffr AbbVie
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development... ...and commercial programs. You will drive global CMC strategies, author Module 2/3 content, and coordinate with...RegulatoryRemote job
- ...Instagram, X and YouTube. The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and... ...patients. Prepares CMC regulatory strategies that enable first pass... ...regulatory affairs department. Leads initiatives internal to RA...RegulatoryLocal area
$150k - $195k
...vision of becoming a leading biopharmaceutical company... ...Position Summary: The Associate Director, Technical Operations (Small Molecule CMC) will provide... ...closely with Quality, Regulatory Affairs, Clinical, and... ...development of risk mitigation strategies. Ability to adapt to...RegulatoryContract workTemporary workRemote work- Travere Therapeutics, based in San Diego, seeks an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API... ...Travere CDMOs. You will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to advance late...RegulatoryRemote job
- BMS is seeking a regulatory affairs leader to develop and oversee global and US regulatory strategies for development teams. You will coordinate internal experts and external resources to address regulatory issues, lead cross-functional teams, and align development plans...Regulatory
- AbbVie is seeking an Associate Director to lead patient-focused strategies for ELAHERE and EMRELIS. You will plan annual brand tactics, align with medical, legal, and regulatory teams, and supervise marketing resources to optimize patient outreach. This hybrid role requires...Regulatory
$195k - $275k
...Kymera is focused on building an industry-leading pipeline of oral small molecule... ...core team member, own early commercial strategy for assigned programs. Develop disease and... ...Partner with Clinical Development, Medical, Regulatory, Research, and Program Leadership to shape...Regulatory$145k - $200k
...Massachusetts LSP for a senior-level position to lead the expansion of our operations. The... ...management, business development, and regulatory expertise. The role includes managing... .... Ultimately, you will shape the growth strategies of our company in New England. We offer...Regulatory- Herzing University seeks an Associate Director of Academic Compliance to provide central support to location and program leaders in regulatory readiness and academic compliance initiatives. The role maintains knowledge of standards, manages compliance activities, and promotes...RegulatoryRemote job
- Avalyn Pharma is seeking a Senior Manager, Regulatory Affairs to shape global regulatory strategy for inhaled drug-device products. You will lead regulatory submissions, health authority... ...will work with Clinical Development, CMC, and Quality teams to ensure compliant deliverables...RegulatoryRemote job
- Jobtailor is seeking a Regulatory Affairs leader to shape a global regulatory vision for assigned products with a patient-centric focus. The role requires building strong partnerships with GRAST, managing interactions with health authorities like the FDA/EMA, and ensuring...Regulatory
- ...Operations About the Role The Director, Study Lead is accountable for end‑to‑... ..., Medical Affairs, Regulatory, Biometrics, Safety, and external... ...the global study operational strategy, timelines, enrollment plan,... ...Development, Regulatory, Safety, CMC, and Program Management to...RegulatoryInterim role
- Regulatory leaders who leverage regional regulatory experience to actively contribute to an... ...sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-... ...GRAST) and other regional, labeling and CMC GRAST members. Ensure bi-directional...Regulatory
- Parkhill is seeking a Grants Administrator to lead strategic administration of federal, state, and local grant programs from identification through closeout. The role combines regulatory interpretation, client leadership, and business development to help communities secure...RegulatoryFull timeLocal area
$150k - $195k
...vision of becoming a leading biopharmaceutical company... ...Position Summary The Associate Director, Technical Operations... ...and international regulatory standards. The... ...making for QC control strategies, and must have extensive... ...colleagues in Analytical, CMC, Quality, and...RegulatoryContract workTemporary workRemote work- Kymera Therapeutics is seeking a senior Regulatory Affairs CMC leader to drive global CMC strategies for degrader programs from early development through NDA/MAA submissions. You will collaborate with CMC, Quality, and Clinical teams to align regulatory plans with program...Regulatory
$150k - $195k
Department: 107000 Regulatory Location: San Diego,... ...vision of becoming a leading biopharmaceutical company... ...Summary: The Associate Director, Regulatory Project Manager... ...Regulatory Affairs Strategy leaders to create regulatory... ...Clinical Operations, CMC, Biostatistics,...RegulatoryTemporary workRemote workShift work- ...Responsibilities Define and lead analytics and AI strategy using modern methodologies, including LLMs, GenAI applications, agentic workflows, and... ...data sources, and AI/ML approaches for pharmacovigilance, regulatory submissions, quality, and clinical data insights....Regulatory
$100 - $150 per hour
...are seeking an experienced Regulatory CMC Consultant to support global... ...programs. Responsibilities Lead or contribute to the authoring... ..., quality, and regulatory strategies for late-stage biologics development... ...preferred. Seniority level Director Employment type Contract...RegulatoryContract workRemote work- ...shaping the end‑to‑end disease strategy. Develops Disease Area... ...currently marketed products. Leads all R&D business development activities... ...development space, relevant regulatory expectations, and overall drug... ...e.g., chemistry/biochemistry, CMC), late development, and...Regulatory
$169.22k - $253k
...3 Position Summary The Associate Director of MSAT (Manufacturing Science... ..., comparability, control strategy implementation, and investigations... ...Key Responsibilities Lead the analytical sciences... ...approve analytical sections of regulatory filings (BLA/MAA, responses...RegulatoryFull timeContract workTemporary workLocal areaRemote workWorldwideFlexible hours$150k - $195k
...pursue our vision of becoming a leading biopharmaceutical company... .... Position Summary The Associate Director, Statistical Programming works... ...publications, responses to regulatory questions). Reviews/... ...flexibility to implement new strategies and tactics to accommodate...RegulatoryTemporary workFor contractorsRemote workShift work- ...product development and brand teams. Implements the diagnostic strategy, including development of supportive arguments for highly... ...incorporation of diagnostic biomarkers into exploratory, clinical, regulatory, and Medical/Commercial strategies. Provides technical...Regulatory
$173k - $212k
...inspires. POSITION SUMMARY: The Associate Director, Corporate Communications... .... This individual will lead Disc’s corporate storytelling... ...with commercial, medical, and regulatory teams to ensure accurate, compliant... ...and Disc’s corporate strategy. KEY RESPONSIBILITIES: External...RegulatoryRemote workFlexible hours- ...PCN 986 Position Overview The Associate Director of Financial Aid provides operational leadership... ...as a key partner in enrollment strategy, student support, and cross-department... ...reviewer for financial aid files to ensure regulatory accuracy, compliance, and ethical processing...RegulatoryWork at officeImmediate startWeekend work
- ...maximize the Neurology portfolio by shaping end‑to‑end disease strategies and leading global development programs. The role partners across... ...proven leadership of large, matrixed teams, and deep knowledge of translational medicine, CMC, and #J-18808-Ljbffr Jobtailor
$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA-... ...our vision of becoming a leading biopharmaceutical company... ...Position Summary: The Director, Regulatory Affairs Strategy is responsible for developing... ...Medical Affairs, Biostatistics, CMC, Quality, Nonclinical,...RegulatoryTemporary workLocal areaRemote workWeekend work$179.15k - $217.08k
## Associate Director, Campus Program LeadDevens - MA - USFind out how well you match with this job... ...**Associate Director, Campus Program Lead** provides leadership to campus projects... ...to gather broad feedback and develop strategy accordingly.* Apply project management...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workMonday to FridayFlexible hoursShift work$145.5k - $205k
...pulmonary hypertension associated with interstitial lung... ...Are The Associate Director, Corporate Compliance... ...role serves as a go-to lead for compliance systems... ...addressing operational and regulatory challenges with... ...and clarity. Data Strategy and Reporting Enablement...RegulatoryFull timeWork at officeRemote work$179.22k - $217.18k
## Associate Director, EHSDevens - MA - USFind out how well you match with... ...will be responsible for leading the company’s Environmental... ...ones.* Provide applicable regulatory and technical practical guidance... ...with company and site strategy at the direction of the site...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
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