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Engineering Jobs in Elyria, OH

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Senior Regulatory Affairs Specialist Hologic Inc

Cambridge, MA

$40,000–$50,000 / year

To deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.

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.

10 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.

5 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.

5 days ago

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

Boston, MA

$30–$55 / hour

4 days ago

Sr Regulatory Affairs Spec Medtronic Plc

Boston, MA

This role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

30+ days ago

Regulatory Affairs Specialist Careerscape

Boston, MA

$90,000–$125,000 / year
Full time

Our client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.

30+ days ago

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Waltham, MA

$116,000–$160,000 / year

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.

30+ days ago

Manager, Regulatory Affairs Deciphera

Waltham, MA

$116,000–$160,000 / year

30+ days ago

Intellia Therapeutics - Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

Intellia Regulatory Affairs Fellowship Program Overview: Northeastern University Pharmaceutical Industry Fellowships Program is a 2-year experiential program designed to advance lifelong learning and the education and training of PharmD graduates. In the second year, the Fellow will have the opportunity to select between the two disciplines, honing skills they developed during the first year and taking a deeper dive into specialized regulatory activities to provide the Fellow with a strong understanding of the drug development and approval landscape, and global regulatory frameworks.

10 days ago

Dompe- Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Boston, MA

$60,315–$85,192.50 / year

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm. With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role.

10 days ago

Regulatory Affairs Fellow MBX Biosciences Inc

Burlington, MA

2 development for the treatment of chronic hypoparathyroidism (HP); imapextide (MBX 1416), in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND currently under FDA review, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The fellow will spend the first 18 months rotating throughout the different functions of the Regulatory Department and may choose to move to another MBX department (eg, Clinical Science, Medical Affairs, Drug Safety/PVG, Commercial, etc…) for a 6-month optional rotation pending management approval.

9 days ago

Senior Regulatory Affairs Specialist Philips

Cambridge, MA

$99,000–$157,000 / year

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.

4 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.

11 days ago

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

Westford, Massachusetts

$129,300–$258,700 / year

Maintains 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; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

18 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.

6 days ago

Head of Regulatory Affairs Pulpdent Corporation

Watertown, MA

Pulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent’s global regulatory strategy across the full product lifecycle—from R&D and commercialization to quality assurance and post-market surveillance.

5 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.

8 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.

10 days ago

VP, Regulatory Affairs Prime Medicine

Cambridge, MA

$313,000–$348,000 / year

8 days ago

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Engineering Jobs in Elyria, OH

Senior Regulatory Affairs Specialist Hologic Inc

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

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

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

Sr Regulatory Affairs Spec Medtronic Plc

Regulatory Affairs Specialist Careerscape

Manager, Regulatory Affairs Deciphera Pharmaceuticals Inc

Manager, Regulatory Affairs Deciphera

Intellia Therapeutics - Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Dompe- Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University

Regulatory Affairs Fellow MBX Biosciences Inc

Senior Regulatory Affairs Specialist Philips

Senior Manager, Regulatory Affairs US Lead AstraZeneca Plc

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

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

Head of Regulatory Affairs Pulpdent Corporation

VP, Regulatory Affairs Prime Medicine Inc

Director, Regulatory Affairs Advertising and Promotions Definium Therapeutics Inc

VP, Regulatory Affairs Prime Medicine

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