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Wine Jobs in Haddonfield, NJ

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Alnylam Pharmaceuticals - Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

Assuming increasing responsibility over the two years, the experience gained throughout this fellowship will allow the Regulatory Affairs fellow to develop a deep understanding of Global Regulatory Strategy across development programs within rare and prevalent diseases and gain project-based exposure across other regulatory affairs disciplines, if interested: Key Job Duties: Support, prepare, and submit a wide range of regulatory filings such as investigational new drug applications, clinical trial applications, new drug applications and international marketing authorization applications. Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.

21 days ago

Director, Regulatory Affairs Sumitomo Pharma America Holdings Inc (Inactive)

Marlborough, MA

$195,900–$244,900 / year

Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS.

15 days ago

Head of Regulatory Affairs Artbio

Cambridge, Massachusetts

Summary The Head of Regulatory Affairs leads ARTBIO’s regulatory function for clinical-stage radiopharmaceutical programs, ensuring clear strategy, compliant execution, and effective engagement with health authorities. Partner with Clinical, CMC, Quality, Nonclinical, Clinical Development and Operations, regulatory consultants, and external publishing partners to support timely, high-quality submissions.

2 days ago

Director, Regulatory Affairs US Lead AstraZeneca Plc

Boston, MA

$186,232.80–$279,349.20 / year

At Alexion (AstraZeneca's Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across subject areas to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and compassion for patients and communities we serve. Role Overview: The Director, Regulatory Affairs US lead will be accountable for the development, implementation, and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

22 days ago

Senior Manager, Regulatory Affairs US Lead Alexion Pharmaceuticals Inc

Boston, MA

$135,624.80–$203,437.20 / year

At Alexion (AstraZeneca's Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across subject areas to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and compassion for patients and communities we serve. Role Overview: The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning, preparing and delivering regulatory strategies and activities for assigned product(s)/project(s) across the assigned jurisdiction supporting global regulatory strategies, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

22 days ago

Head of Regulatory Affairs TRIMAREN

Watertown, MA

In partnership with Research, Clinical Development, CMC, Quality, and senior leadership, you will help ensure regulatory decisions are grounded in rigorous science, aligned with global expectations, and positioned to support accelerated development for transformative therapies. Lead preparation, review, and submission of high-quality regulatory documents, including IND/CTA amendments, briefing packages, meeting requests, annual reports, and related agency correspondence.

13 days ago

Senior Director, Regulatory Affairs Artbio

Cambridge, Massachusetts

12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry, including demonstrating leadership in leading the deliverables for regulatory interactions supporting pre-IND to Phase 3 investigational-stage programs in oncology. Translates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programs.

2 days ago

Vice President, Regulatory Affairs Editas Medicine, Inc.

Cambridge, MA

$345,000–$372,000 / year

Reporting to the Chief Medical Officer, this hands-on leader will oversee all regulatory activities from development candidate selection through clinical development and marketing authorization, including leading interactions with global health authorities, authoring and managing submissions, establishing regulatory processes and systems, and shaping evidence-generation strategies for innovative gene editing products in an evolving regulatory landscape. Decoding The Role: The Vice President, Regulatory Affairs will lead and build the global regulatory function and strategy for a growing portfolio of in vivo gene editing therapies, serving as the company's primary regulatory expert and strategic advisor to executive leadership, program teams, the Board, and external partners.

15 days ago

Vice President, Regulatory Affairs Editas Medicine

Cambridge, MA

$345,000–$372,000 / year

Reporting to the Chief Medical Officer, this hands-on leader will oversee all regulatory activities from development candidate selection through clinical development and marketing authorization, including leading interactions with global health authorities, authoring and managing submissions, establishing regulatory processes and systems, and shaping evidence-generation strategies for innovative gene editing products in an evolving regulatory landscape. Lead product-quality regulatory strategy and execution, working directly with CMC and Quality colleagues to develop submission content addressing control strategy, potency, specifications, analytical validation, manufacturing changes, comparability, and lifecycle considerations for gene editing components and delivery systems.

14 days ago

Director, Global Regulatory Affairs Stoke Therapeutics Inc

Bedford, MA

$248,000–$280,000 / year

Position Purpose: The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.

30+ days ago

Regulatory Affairs Director *PC 954 Miltenyi Biotec GmbH

Boston, MA

$201,579–$237,206 / year

These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Essential Duties and Responsibilities: Develop and implement CMC regulatory strategies to support clinical development, marketing applications, and post-approval lifecycle management for cell and gene therapy products.

30+ days ago

Director, Global Regulatory Affairs Stoke Therapeutics, Inc.

Bedford, MA

$248,000–$280,000 / year

30+ days ago

RA Lead- Regulatory Affairs, SQR Fresenius Medical Care AG & Co KGaA

Waltham, MA

Represent Regulatory Affairs within the SQR leadership team in India and work enabling functions on workforce planning, hiring, engagement, retention and site-level matters, while functional ownership of the work remains with global SQR. Hold end-to-end accountability for regulatory deliverables as an integral part of the global and regional RA teams: registration dossiers, technical documentation, submissions, renewals and lifecycle maintenance across the U.S., EU, LATAM, and APAC.

30+ days ago

Director or Senior Director, Regulatory Affairs Kymera Therapeutics

Watertown, MA

$195,000–$330,000 / year

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Act as the global regulatory strategy lead for Kymera's IRF5 degrader program, developing and driving the overall program regulatory strategy across multiple immunology and inflammation (I/I) indications.

30+ days ago

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Watertown, MA

$145,000–$215,000 / year

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies.

30+ days ago

Regulatory Affairs Coordinator - Urology Mass General Brigham

Boston, Massachusetts

$20.16–$29.01 / hour

Maintains regulatory documentation for assigned studies in accordance with institutional requirements, sponsor requirements, federal regulations, and GCP guidelines.-Manage adverse events and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success.

30+ days ago

Vertex - Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.

21 days ago

Director, Regulatory Affairs Arbor

Cambridge, Massachusetts

Lead cross‑functional planning of regulatory submissions and amendments, including IND submissions to FDA, and provide regulatory oversight of CRO‑led regulatory activities and submissions outside the United States. The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning preclinical and early clinical stages.

30+ days ago

Executive Director, Regulatory Affairs Dyne Therapeutics Inc

Waltham, MA

$250,000–$310,000 / year

Role Summary: The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne''s regulatory operations. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization''s direction, and ensures alignment with the mission of delivering meaningful outcomes for patients.

30+ days ago

Director, Regulatory Affairs CMC Vertex Pharmaceuticals Inc

Boston, MA

$190,400–$285,600 / year

General Summary: The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans.

30+ days ago

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Wine Jobs in Haddonfield, NJ

Alnylam Pharmaceuticals - Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Director, Regulatory Affairs Sumitomo Pharma America Holdings Inc (Inactive)

Head of Regulatory Affairs Artbio

Director, Regulatory Affairs US Lead AstraZeneca Plc

Senior Manager, Regulatory Affairs US Lead Alexion Pharmaceuticals Inc

Head of Regulatory Affairs TRIMAREN

Senior Director, Regulatory Affairs Artbio

Vice President, Regulatory Affairs Editas Medicine, Inc.

Vice President, Regulatory Affairs Editas Medicine

Director, Global Regulatory Affairs Stoke Therapeutics Inc

Regulatory Affairs Director *PC 954 Miltenyi Biotec GmbH

Director, Global Regulatory Affairs Stoke Therapeutics, Inc.

RA Lead- Regulatory Affairs, SQR Fresenius Medical Care AG & Co KGaA

Director or Senior Director, Regulatory Affairs Kymera Therapeutics

Senior Manager, Regulatory Affairs Kymera Therapeutics Inc

Regulatory Affairs Coordinator - Urology Mass General Brigham

Vertex - Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Director, Regulatory Affairs Arbor

Executive Director, Regulatory Affairs Dyne Therapeutics Inc

Director, Regulatory Affairs CMC Vertex Pharmaceuticals Inc

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