Associate Director / Director, Regulatory Affairs
Treeline
About The Role We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities to ensure compliance with applicable laws, regulations, and guidelines. In this role, you will contribute to and help implement regulatory strategy, prepare and manage regulatory submissions, and help guide the company through complex regulatory landscapes. The successful candidate will have experience in, and enthusiasm for, working in a small, dynamic environment with broad responsibilities. #J-18808-Ljbffr Treeline
$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent...SuggestedFull timeLocal area- ...pipeline of differentiated investigational therapeutic candidates for well-validated targets.Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to...SuggestedTemporary workWork at officeLocal areaImmediate start3 days per week
$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS programs. The role will lead the regulatory strategy and facilitate submission of data packages to the US. The role is...SuggestedFull timeTemporary workLocal areaFlexible hours2 days per week$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic...SuggestedWork at officeWork from home- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...
$200k - $240k
...across the spectrum of antibody-driven diseases. The Associate Director, Regulatory Operations will play a key role in supporting global regulatory... ...lifecycle management, working closely with Regulatory Affairs leadership and cross-functional teams to ensure high-...Work at officeLocal area- ...pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to...Work at office3 days per week
$175k - $206.02k
Associate Director / Director, Regulatory Affairs About the Role We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing...$170k - $230k
Associate Director, Regulatory Affairs CMC Waltham, MA Skyhawk Therapeutics is seeking a hands‑on Associate Director, Regulatory Affairs CMC (RegCMC) to support the development and execution of the global RegCMC strategy for Skyhawk's small molecule pipeline. Working...- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. The Associate Director, Global...Full timeRemote workWorldwide
$171k - $209k
...possibilities of what we can do together. How You Will Achieve More:The Associate Director, Healthcare Compliance, will play a critical role in... ...through close partnership with the Commercial and Medical Affairs organizations, cross-functional collaboration, and a...Full time$182k - $208k
...difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Associate Director, Regulatory CMC (Biologics) Location: Hybrid – Waltham, MA . Candidates will be required to be in-office3 days/week. We...Full time$154.4k - $242.55k
...global strategies to maximize global regulatory success towards achievement of program... ...regional counterparts.Accountabilities:The Associate Director will be responsible for complex or... ...understanding broad concepts within regulatory affairs and implications across the...Minimum wageTemporary workLocal areaRemote work$154.4k - $242.55k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...Minimum wageTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
...radically changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management &... ...capabilities, and partner closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise...Permanent employmentFull timeFor contractorsWork at officeWork from home- ...help them achieve their goals.Job DescriptionReporting to the Director of the Office for Community Support, Non-Discrimination, Rights... ...(CSNDR) and University Title IX Coordinator, the Associate Director for Compliance and Title VI Coordinator is responsible...Work at officeLocal area
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic...Permanent employmentWork at office- Amylyx Pharmaceuticals seeks an Associate Director, Legal & Compliance to join its Legal Department and support a broad range of daily advising across contracting, compliance, risk management, employment law, and privacy. This role will involve collaboration with the Data...Remote job
- Conditions. Workplace Diversity, LLC. is looking for an Associate Director for Compliance in Cambridge, MA. The role involves oversight of compliance with Title VI and case management for Title IX Hearings. You will collaborate closely with the Office for Community Support...Work at office
- A prestigious educational institution is seeking an Associate Director for Compliance and Title VI Coordinator. This role involves oversight of compliance with Title VI, managing Title IX hearings, and supervising a compliance team. Candidates must have a J.D. and significant...
$153.54k - $230.31k
Associate Director, Standards, Compliance & Training, MSRM Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with...Contract workTemporary workWork at officeRemote workWork from homeFlexible hours3 days per week- Agios Pharmaceuticals is seeking an Associate Director, Standards, Compliance & Training within the Medical Safety and Risk Management (MSRM... ...to support vendor oversight, case quality expectations, and regulatory submissions, while driving continuous improvement and...
$259k - $317k
...empowered to make an impact — both within our company and in the lives of patients we serve.Position Summary:The Senior Director of Regulatory Affairs is a senior leader responsible for developing and executing global regulatory strategy across the product portfolio....Full timeWork at officeFlexible hours- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East Coast, USA) Employment Type: Full-time, Permanent About the Company Our client is a growing consultancy supporting innovative biotechnology and pharmaceutical...Permanent employmentFull time
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of Moderna... ...agencies for assigned programs. May serve as regulatory affairs representative to provide input on clinical trials and...
- ...leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires extensive experience in regulatory affairs, particularly in oncology, to ensure alignment between US and global...
- Novartis Group of Companies in Cambridge, MA seeks an Associate Director to provide global, end-to-end nonclinical safety leadership across... ...interactions with global Health Authorities to ensure robust, regulatory-compliant safety strategies that enable clinical trial...
- Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director of Clinical Compliance & Records responsible for ensuring compliance with clinical study regulations. The ideal candidate will have extensive experience in the pharmaceutical industry, guiding Study...
$171k - $192k
Associate Director, Clinical Compliance & Records Cambridge, MA Amylyx has an audacious mission to usher in a new era for treating diseases... ...of ICH‑GCP standards, FDA guidelines, and other applicable regulatory requirements throughout the clinical trial lifecycle. Apply...Local areaRemote work
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