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Regulatory Affairs
Most Pharmaceutical, Biotechnology, Medical Device and Life Science companies are hiring for Regulatory Affairs professionals. Our clients are no different and on this page you will find their open regulatory career opportunities.
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Associate Director, Medical Writing

Amicus Therapeutics - Cranbury, NJ

Requirements - The ideal candidate will possess a graduate level education - A minimum of 4 to 8 years' experience with related work within a pharmaceutical company or CRO; all clinical or clinical research experience will be considered Location - This position will be based at 1 Cedar Brook Drive, Cranbury, NJ, 08512 - Majority of time (eg, 3 of every 5 days) are to be onsite Travel...more

From Amicus Therapeutics - 6/22/2018 6:24:16 AM

Associate Director, Global Regulatory Affairs Compliance - Small Molecule Post Approval

Merck & Co. - West Point, PA

Education: • B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Required: •At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields. •The candid...more

From Merck & Co. - 6/22/2018 6:23:39 AM

Director, Regulatory Affairs CMC - Small Molecule Post-Approval

Merck & Co. - Whitehouse Station, NJ

Education: The candidate should possess an advanced degree in science (PhD preferred) with at least 15 years or more of experience in pharmaceutical industry (10 years with an advanced degree). The ideal candidate will have: • strong experience in regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufactu...more

From Merck & Co. - 6/22/2018 6:23:39 AM

Project Manager Drug Safety

Covance, Inc. a division of LabCorp® - Princeton, NJ

Education/Qualifications Level of education required (or experience level which may be substituted for level of education). Professional designations/certifications/licenses required. - Non - degree + 6 to 7 years safety experience - Associate degree +5 to 6 years safety experience - Associate degree RN +5 to 6 years safety experience - BS/BA +4 to 5 years safety experience - MS...more

From Covance, Inc. a division of LabCorp® - 6/22/2018 6:23:01 AM

Medical Advisor Respiratory, Inflammation and Autoimmune disease (RIA)

AstraZeneca Pharmaceuticals - Vilnius, 

Accountabilities •Develop peer-to-peer relationships and cooperation with Key External Experts (KEEs), other important decision makers, and researchers in a way that is consistent with the overall company strategy and objectives •Drive proactive and reactive customer interactions by collecting and sharing medical and scientific knowledge across the portfolio •Acts as a Baltic and/or local me...more

From AstraZeneca Pharmaceuticals - 6/21/2018 5:49:16 AM

Senior Associate Advertising and Promotion Review

Amicus Therapeutics - Cranbury, NJ

- Candidate must possess at least 3 years of regulatory experience in the pharmaceutical or biotechnology industry. Experience with Regulatory Affairs Advertising and Promotion is a plus. - Knowledge of global regulations, guidance documents, and initiatives related to Advertising and Promotion and labelling requirements. - Strong communication skills (oral, written, and interpersonal)...more

From Amicus Therapeutics - 6/20/2018 5:45:43 AM

Sr. Specialist, Regulatory Affairs, CMC - Post Approval

Merck & Co. - Rahway, NJ

Education Requirement: •B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Required Experience and Skills: •At least two (2) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing or a related fie...more

From Merck & Co. - 6/20/2018 5:44:02 AM

Office Manager, Government Affairs (Washington, DC office)

Novartis Pharmaceuticals - Washington, DC

EDUCATION: Bachelor Degree is required. EXPERIENCE: 7+ years of related working experience required, preferably in legal, HR, government affairs from a large matrixed organization. Experienced in large organizational culture, relationships and interpersonal dynamics as well as external environment and trends Experienced working across various Line functions to ensure deliverables are met ...more

From Novartis Pharmaceuticals - 6/20/2018 5:43:41 AM

Regulatory Affairs Analyst

Novartis Pharmaceuticals - Fort Worth, TX

•Fluent in verbal and written English communication skills. •Bachelor's degree in a related field and/or equivalent combination of education and work experience.

From Novartis Pharmaceuticals - 6/19/2018 5:45:27 AM

Regulatory Affairs Manager

Novartis Pharmaceuticals - Fort Worth, TX

• Fluent in verbal and written English communication skills. • Bachelor's degree in a related field with 5+ years of directly related working experience OR equivalent

From Novartis Pharmaceuticals - 6/19/2018 5:45:27 AM

Global Marketing Director, Biomarker & Diagnostics

Merck & Co. - Kenilworth, NJ

Education: • Required: Bachelors • Preferred: MSc and MBA or PhD Required Experience: • Minimum of (5) years Diagnostic Business experience • Minimum of (3) years Pharmaceutical Business experience • Oncology Marketing experience • Pharmaceutical & Diagnostics marketing experience • Diagnostic Product Launch experience • Significant & demonstrated commercial leadership in m...more

From Merck & Co. - 6/19/2018 5:44:50 AM

Global Technical Director - Swine

Merck & Co. - Madison, NJ

• A degree in Veterinary Medicine DVM. • A minimum of 10 years of relevant experience in the Animal Health Industry and/or Swine production or academia. • Full proficiency in spoken and written English (proficiency in second major language is preferred) • Excellent verbal and written communication skills, including intercultural, interpersonal and general communication with a natural ability to...more

From Merck & Co. - 6/19/2018 5:44:50 AM

Sr. Specialist, Regulatory Affairs, Site CMC

Merck & Co. - West Point, PA

Education Minimum Requirement: The candidate must possess a relevant Bachelor's degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences, etc.). Required Experience and Skills: A minimum of 3 years of experience in the pharmaceutical industry in a regulatory, compliance, technical or quality role. The candidate must have a some experience (1-2 yea...more

From Merck & Co. - 6/19/2018 5:44:50 AM

Regional Quality & Compliance Associate

Merck & Co. - Upper Gwynedd, PA

Education Minimum Requirement: • Bachelor's Degree or equivalent in relevant health care area with a minimum of 5 - 7 years of working experience in with or within a compliance or quality function. Required Experience and Skills: • Knowledge and understanding of regulatory & PV processes; as well as, quality management and control tools is required • Extensive experience in managing a cul...more

From Merck & Co. - 6/18/2018 5:38:06 AM

Pharmacovigilance (PV) Scientist

Glenmark Pharmaceuticals Inc., USA - Mahwah, NJ

Key Responsibilities : - Serve as the primary role for triage and quality control (QC) of individual case safety reports (ICSR) ensuring that adverse event reports are reviewed and processed in a timely manner, and in accordance with the appropriate company SOPs (standard operating procedures), study protocols and regulatory guidelines (mainly SUSAR reports) - Work with the clinical proje...more

From Glenmark Pharmaceuticals Inc., USA - 6/15/2018 5:58:38 AM

Senior CMC, Regulatory

Glenmark Pharmaceuticals Inc., USA - Paramus, NJ

Key Responsibilities : - Accountable for the development and implementation of innovative regulatory strategies with a strong emphasis on CMC biologics for assigned projects in accordance with applicable US and EU legislation that maximize the likelihood of rapid development and timely registration - Serve as the Regulatory Affairs (RA) lead representative on the Product Development Team ...more

From Glenmark Pharmaceuticals Inc., USA - 6/15/2018 5:58:38 AM

Senior Strategy, Oncology

Glenmark Pharmaceuticals Inc., USA - Paramus, NJ

Key Responsibilities : - Accountable for the development and implementation of innovative regulatory strategies for the project in accordance with applicable US and EU legislation that maximize the likelihood of rapid development and timely registration - Serve as the Regulatory Affairs (RA) lead representative on the Product Development Team - Lead the development, communication and upd...more

From Glenmark Pharmaceuticals Inc., USA - 6/15/2018 5:58:38 AM

Senior Manager - Regulatory

Glenmark Pharmaceuticals Inc., USA - Monroe, NC

Key Responsibilities : - Coordinate ANDA submissions to FDA, interact with regulatory agencies, serve as point of contact to local regulatory authorities, ensure progress on project teams, address state regulatory requirements, and coordinate with marketing for provincial submissions. - Perform change control evaluation; Identify need for new regulatory policies and implement new regulat...more

From Glenmark Pharmaceuticals Inc., USA - 6/15/2018 5:58:38 AM

Manager/Senior Manager, Regulatory Affairs

Glenmark Pharmaceuticals Inc., USA - Paramus, NJ

Key Responsibilities : - Support the global regulatory lead in the implementation and development of innovative regulatory strategies for assigned projects with the objectives of successful development and timely registration. - Planning, writing, compiling and/or reviewing routine regulatory submissions (annual reports, amendments, etc.) to support ongoing research and product regist...more

From Glenmark Pharmaceuticals Inc., USA - 6/15/2018 5:58:38 AM

Director, Global Regulatory Lead, Regulatory Affairs Oncology

Merck & Co. - Rahway, NJ

Education: •B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs •M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs •M.D. with minimum of 5 years regulatory experience •PhD with minimum of 7 years relevant regulatory experience Required: •A...more

From Merck & Co. - 6/14/2018 5:48:00 AM
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