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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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Quality Systems Administrator

Glenmark Pharmaceuticals Inc., USA - Monroe, NC

Education : - Minimum Associate's degree in scientific discipline (or closely related technical field of study) - Direct experience as a MasterControl Administrator may be used in lieu of degree requirements Experience: - MasterControl Implementation experience preferred. - Minimum of one (1) year of MasterControl Administrative experience required. - Prior pharmaceutic...more

From Glenmark Pharmaceuticals Inc., USA - 6/18/2018 5:41:23 AM

Software Quality Systems Manager - Mobile Medical Device Applications

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Main Duties and Responsibilities Quality professional with strong subject knowledge, both in depth and breadth. Role is responsible for the development, maintenance, and continuous improvement of Software Development Life Cycle programs, systems, and procedures governing connected devices and mobile medical device apps including software that is a medical device. Will also manage, oversee, and/o...more

From AstraZeneca Pharmaceuticals - 6/18/2018 5:41:10 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

Sr Assoc Drug Safety

Covance, Inc. a division of LabCorp® - Japan, Tokyo-to

Education/Qualifications - Non-degree + 5-6 yrs safety experience* - Associate degree + 4-5 yrs safety experience* - Associate degree RN + 4-5 yrs safety experience* - BS/BA + 3-4 yrs safety experience* - MS/MA + 2-3 yrs relevant experience** (1-2 yrs safety experience) - PharmD + 1-2 yrs relevant experience** (1 yr safety experience) - For PharmD, a one year resid...more

From Covance, Inc. a division of LabCorp® - 6/12/2018 5:44:32 AM

Associate Director, Promotional Regulatory Affairs - CVMD

AstraZeneca Pharmaceuticals - Wilmington, DE

Typical Accountabilities: •Responsible for efficient and effective regulatory review of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other  materials required to be reviewed through AZAP •Conducts reviews with...more

From AstraZeneca Pharmaceuticals - 6/12/2018 5:44:00 AM

Executive Regulatory Science Director, Oncology

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Main Duties and Responsibilities Disease Area Regulatory Strategies You will partner with the Regulatory Affairs Directors (RADs) to align on the regulatory strategy for a product(s) and ensure it is consistent with the disease area or TA portfolio strategy. You will provide critical review and input on disease area or portfolio regulatory strategies, risk planning and mitigations. You will ensu...more

From AstraZeneca Pharmaceuticals - 6/12/2018 5:43:59 AM

Quality Associate - Supplier Quality Management

Catalent Pharma Solutions - Braeside, Victoria

Job Description We are currently seeking an experienced Quality Associate to work within the Quality & Regulatory Affairs Department - Compliance Team on Supplier Quality Management (SQM) covering; •Administering the SQM system •Managing the Trackwise Supplier Quality Management system module •Ensuring all aspects of our Supplier Quality Management Program are met •Finalising Raw Mate...more

From Catalent Pharma Solutions - 6/11/2018 5:50:43 AM

Senior Policy Director

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Accountabilities/Responsibilities: Internal Engagement •Build internal networks on complex regulatory topics. •Create and manage overall internal engagement strategy. •Manage relationship with senior management in policy and non-policy groups, e.g., legal, TAVPs, etc. •Engaging GRA stakeholders including TA VPs and Executive Regulatory Affairs Directors to help facilitate appropriate disea...more

From AstraZeneca Pharmaceuticals - 6/11/2018 5:49:17 AM

Senior Specialist, Global Regulatory Affairs Clinical Safety- Business Development & Licensing

Merck & Co. - Upper Gwynedd, PA

Education: • Required: Bachelor's Degree • Preferred: Degree concentration in Technical discipline (science, engineering) or Life Sciences (Biology, Chemistry, Nursing, Pharmacy) or related discipline Required: • A minimum of five (5) years pharmaceutical or relevant professional experience Preferred: • Knowledge of regulatory and CMC processes for pharmaceutical products, vaccines an...more

From Merck & Co. - 6/11/2018 5:49:01 AM

Submission Manager

Novartis Pharmaceuticals - East Hanover, NJ

EDUCATION: Bachelor's degree or equivalent education/degree in life science/healthcare is required. LANGUAGE: Fluent English (oral and written) EXPERIENCE: • = 2 years' experience in Clinical research with proven proficiency in global Clinical development • Fundamental leadership of cross-functional teams. Has demonstrated teamwork, communication and organizational skills. Works effectively and...more

From Novartis Pharmaceuticals - 6/11/2018 5:48:34 AM

Director, Regulatory Affairs/Labeling

Merck & Co. - Rahway, NJ

Education Requirement: • B.S. in a scientifically or medically-related discipline or other relevant degree. • Master's degree preferred. Required Experience : • Minimum of 10 years pharmaceutical/biological labeling experience or relevant professional experience. Regulatory submission experience. • Expertise in labeling regulations. • Detail oriented, well organized, and excell...more

From Merck & Co. - 6/8/2018 5:49:53 AM

Manager, Compliance and Reporting

Novartis Pharmaceuticals - Fort Worth, TX

Bachelor's degree or equivalent years of experience. Minimum of 5 years directly related experience with a Bachelor's degree

From Novartis Pharmaceuticals - 6/8/2018 5:49:38 AM

Director, Quality Control

Catalent Pharma Solutions - Madison, WI

The Role • Manages the Bioanalytical and Microbiological Services department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems. •Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in ...more

From Catalent Pharma Solutions - 6/7/2018 5:46:49 AM

Associate Director / Director, Regulatory Advertising and Promotions

Novartis Pharmaceuticals - East Hanover, NJ

Position will be filled at level commensurate with experience. BA/BS Degree required, Advanced degree preferable (MS, MD, PhD, PharmD, or JD) • Minimum 5 years of experience in clinical, regulatory or related experience in the pharma industry • Excellent understanding of US regulations for drug promotion/advertising and US labeling. • Experience in the regulatory review of professional and con...more

From Novartis Pharmaceuticals - 6/7/2018 5:45:09 AM
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