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Pipeline Jobs in Sugar Hill, GA

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Director, Global Regulatory Affairs, Neuroscience Takeda

Boston, Massachusetts

Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

30+ days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals

Waltham, Massachusetts

$116,000–$160,000 / year
Full time

ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

4 days ago

VP, Regulatory Affairs Prime Medicine Inc

Cambridge, MA

$313,000–$348,000 / year

Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies.

22 days ago

Global Regulatory Affairs Manager, Oncology GSK plc

Waltham, MA

$138,750–$231,250 / year

GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions.

11 days ago

Director, Regulatory Affairs Advertising and Promotions Definium Therapeutics Inc

Cambridge, MA

$215,000–$255,000 / year

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, and Legal functions for the purpose of providing regulatory advice and guidance during promotional plan development from concept to field implementation, assuring conformity with FDA requirements, PhRMA DTC Guidelines, and Definium policies.

24 days ago

Senior Manager, Regulatory Affairs US Lead AstraZeneca Plc

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.

25 days ago

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Full time

Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.

30+ days ago

Regulatory Affairs Specialist II Boston Scientific

Marlborough, MA

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. The role will also develop regulatory strategies and provide support for new business development efforts involving external manufacturers, including original equipment manufacturers (OEMs) and contract manufacturers.

30+ days ago

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Westford, Massachusetts

$129,300–$258,700 / year

Lead regulatory strategy for on-market and sustaining activities, including product changes, regulatory impact assessments, maintenance of existing registrations/approvals, and other post-market regulatory activities throughout the product lifecycle. Maintain expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicate such knowledge to all internal stakeholders.

8 days ago

Associate Director, Global Regulatory Affairs CMC Takeda

Boston, Massachusetts

Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. 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 critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.

30+ days ago

Director, Regulatory Affairs, Global Labeling Strategy US Alnylam Pharmaceuticals Inc

The Director of Global Labeling (GL) US will play a lead role in building and refining Alnylam's global labeling strategy processes and capabilities; supervise junior labeling strategists and provide strategic guidance in the development and maintenance of Company Core Data Sheets (CCDS), country product information (CPI) for Alnylam's products, and development of Target Label Profiles (TLP) for investigational therapies or uses. Ensure the implementation of differentiated global labeling strategies and Target Label Profiles that articulate the intended product value, priority claims, evidence requirements, risks, and negotiation pathways.

24 days ago

Spring 2027 Co-Op, Global Regulatory Affairs - Strategy And Operations Vertex Pharmaceuticals, Inc

Boston, MA

$30–$55 / hour

For the reports and activities that occur on a set cadence - quarterly off-site meetings, goals progress, organizational changes and new starters/leavers (announcements, org charts), hiring updates, organizational health - automate updates, including mechanisms for collecting or implementing inputs with scheduled, tracked workflows that can be adjusted in real time. Transition Support: Work in close collaboration with Chief of Staff to support an active key transition project within GRA, through involvement in developing work products/plans, tracking key milestones, and building content to support integration activities, as needed.

19 days ago

Spring 2027 Co-op, Global Regulatory Affairs - Strategy and Operations Vertex Pharmaceuticals Inc

Boston, MA

$30–$55 / hour

18 days ago

Spring 2027 Co-op, Global Regulatory Affairs – Strategy and Operations Vertex Pharmaceuticals

Boston, Massachusetts

For the reports and activities that occur on a set cadence – quarterly off-site meetings, goals progress, organizational changes and new starters/leavers (announcements, org charts), hiring updates, organizational health - automate updates, including mechanisms for collecting or implementing inputs with scheduled, tracked workflows that can be adjusted in real time. Working under the guidance of the Chief of Staff, the co-op student will help organize, develop, and drive key activities across GRA, including but not limited to RALT operating rhythms, department activities, recurring reporting for leadership, and current strategic initiatives in the department.

19 days ago

AstraZeneca -CVRM Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

The CVRM Regulatory Affairs Fellow is not only a learning and development opportunity to understand the drug development process and the Regulatory Affairs role - this role provides strategic and operational regulatory support to the development, commercialization and life cycle management of assigned products. As experience increases, the Fellow will have increasing responsibility and may serve as the regional regulatory lead for assigned programs, contributing to crafting and implementing the clinical strategy and influencing stakeholders to improve outcomes.

24 days ago

VP, Legal and Head of Regulatory Affairs - Patriot Hydro LS Power Development, LLC

Manchester, New Hampshire

Full time

Draft, review, and negotiate power purchase agreements, renewable attribute agreements, hedging and trading documents, interconnection agreements, equipment and service contracts, operations and maintenance agreements, real estate documents, easements, access agreements, confidentiality agreements, and other commercial contracts. Success will be measured by the quality and responsiveness of legal support, reliable execution of licensing and compliance obligations, constructive agency and stakeholder relationships, effective management of legal and regulatory risk, and the development of a consistent portfolio-wide legal and regulatory framework.

20 days ago

Senior Regulatory Affairs Specialist Smith & Nephew Plc

Mansfield, MA

$101,500–$152,250 / year

The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. As a Senior Regulatory Affairs Specialist, you will play a key role in developing regulatory strategies, securing global product approvals, and ensuring compliance throughout the product lifecycle.

30+ days ago

Associate Director Advertising and Promotion, Global Regulatory Affairs Biogen

Cambridge, Massachusetts

$152,000–$209,000 / year

The role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

30+ days ago

Associate Director Advertising And Promotion, Global Regulatory Affairs Biogen Idec

Cambridge, MA

$152,000–$209,000 / year

30+ days ago

Global Regulatory Affairs Manager, Oncology GSK, Plc.

Waltham, MA

$138,750–$231,250 / year

4 days ago

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Pipeline Jobs in Sugar Hill, GA

Director, Global Regulatory Affairs, Neuroscience Takeda

Manager, Regulatory Affairs Deciphera Pharmaceuticals

VP, Regulatory Affairs Prime Medicine Inc

Global Regulatory Affairs Manager, Oncology GSK plc

Director, Regulatory Affairs Advertising and Promotions Definium Therapeutics Inc

Senior Manager, Regulatory Affairs US Lead AstraZeneca Plc

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Regulatory Affairs Specialist II Boston Scientific

Associate Director Regulatory Affairs – Vascular (on-site) Abbott

Associate Director, Global Regulatory Affairs CMC Takeda

Director, Regulatory Affairs, Global Labeling Strategy US Alnylam Pharmaceuticals Inc

Spring 2027 Co-Op, Global Regulatory Affairs - Strategy And Operations Vertex Pharmaceuticals, Inc

Spring 2027 Co-op, Global Regulatory Affairs - Strategy and Operations Vertex Pharmaceuticals Inc

Spring 2027 Co-op, Global Regulatory Affairs – Strategy and Operations Vertex Pharmaceuticals

AstraZeneca -CVRM Regulatory Affairs Postdoctoral Research Fellow Northeastern University

VP, Legal and Head of Regulatory Affairs - Patriot Hydro LS Power Development, LLC

Senior Regulatory Affairs Specialist Smith & Nephew Plc

Associate Director Advertising and Promotion, Global Regulatory Affairs Biogen

Associate Director Advertising And Promotion, Global Regulatory Affairs Biogen Idec

Global Regulatory Affairs Manager, Oncology GSK, Plc.

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