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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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Director, Regulatory Affairs CMC (Business Process Lead)

Merck & Co. - West Point, PA

From Merck & Co. - 8/16/2018 6:04:07 AM

Local Study Team Leader

AstraZeneca Pharmaceuticals - Wilmington, DE

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of the flexible capacity mode...more

From AstraZeneca Pharmaceuticals - 8/16/2018 6:03:48 AM

Local Study Team Leader

AstraZeneca Pharmaceuticals - Wilmington, DE

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of the flexible capacity mode...more

From AstraZeneca Pharmaceuticals - 8/16/2018 6:03:48 AM

Head, Endocrinology Medical Affairs

Novartis Pharmaceuticals - Princeton, NJ

Education: MD, DO, MD/PhD Board certification in Endocrinology or Internal Medicine preferred. Experience/Professional Requirement: Experience: •At least 7 years pharmaceutical industry experience •Experience in the design/implementation of medical affairs studies •Strong background in endocrinology and biologics •Experience in Endocrinology •Historic clinical practice in relevant therapeutic ar...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:33 AM

Head, Immunology Medical Affairs

Novartis Pharmaceuticals - Princeton, NJ

MD, DO, MD/PhD Board certification in Rheumatology, Dermatology, Gastroenterology, or Internal Medicine preferred. 10 years pharmaceutical industry experience required Experience in the design/implementation of medical affairs studies Strong background in immunology and biologics Experience in rheumatology, or dermatology and gastroenterology (with experience in immune-mediated diseases within ...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:33 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 - 8/16/2018 6:03:32 AM

Director US Regulatory Affairs Ad & Promo

Novartis Pharmaceuticals - Fort Worth, TX

Bachelor's required English 10 years directly related experience Class 3 Med Device experience preferred Med Device promotional review experience Healthcare/Med Device Industry experience

From Novartis Pharmaceuticals - 8/16/2018 6:03:32 AM

Director Government Affairs

Novartis Pharmaceuticals - Fort Worth, TX

Bachelor's degree or equivalent combination of education and relevant experience. English required. Master's degree preferred. Minimum 10 years of professional experience Preferred: at least 5 years of related policy experience, including medical device industry experience, or government experience. Experience in public policy, the FDA, and working with industry associations, patient groups, and ...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:32 AM

Senior Investigator, PK Sciences (Associate Director)

Novartis Pharmaceuticals - Cambridge, MA

Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent. 6+years of relevant post-doctoral, academic, industry or government experience. Expert knowledge of biologics and/or small molecule research and development (immunotherapeutics, ADCs) and/or in-depth knowledge of related disciplines (e.g., DMPK, organic chemistry, Oncology, translational medicine, bios...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:31 AM

Senior Regulatory CMC Facilitator

Novartis Pharmaceuticals - Morris Plains, NJ

Education: Bachelor's degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) required. Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) preferred. Languages: Fluent English (oral & written). Experience: 6 - 8 years of experience in pharmaceutical manufacturing site and/or QA/QC or in technical development; comprehensive know-h...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:30 AM

Associate Director, Regulatory Affairs - Device

Novartis Pharmaceuticals - Princeton, NJ

BA/BS/MS/Ph.D. in Biological or Pharm Sci-ence. Required BA/BS, Preferred MS/PhD. • Fluent in English required 7-10 years regulatory or related experience in the pharmaceutical industry. Excellent written and verbal communication skills. Knowledge of regulatory requirements, guidance's and regulations (US) within the pharmaceutical industry, specific to the areas of clinical research, product deve...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:29 AM

Regulatory Affairs CMC Team Lead - Cell and Gene Therapy

Novartis Pharmaceuticals - East Hanover, NJ

Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Sciences (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent discipline. Fluent English required (oral and written). Good skills in site (local) language desired (oral) 1. 8 years in experience in biopharmaceuticals and/or cell and gene therapy, at...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:29 AM

Global Program Regulatory Director

Novartis Pharmaceuticals - East Hanover, NJ

Bachelor's degree English 10 years directly related experience Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Languages: Fluency in English as a business language. Additional language is an asset. Experience: Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:29 AM

Global Program Safety Lead (GPSL)

Novartis Pharmaceuticals - Cambridge, MA

Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French,...more

From Novartis Pharmaceuticals - 8/16/2018 6:03:29 AM

Temp 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 proj...more

From Glenmark Pharmaceuticals Inc., USA - 8/16/2018 6:03:04 AM

Senior Director 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 - 8/16/2018 6:03:04 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 - 8/16/2018 6:03:04 AM

Senior Associate, Labeling Strategist, Regulatory Affairs

Glenmark Pharmaceuticals Inc., USA - Paramus, NJ

Key Responsibilities : - Provide labeling guidance to all Regulatory team and all cross-functional stakeholders to ensure Glenmark drug product labeling is compliant with all applicable regulations and guidance. - Manage labeling elements with external collaborations in accord with stated departmental and corporate timelines. - Provide regulatory support for original ANDAs, responses to de...more

From Glenmark Pharmaceuticals Inc., USA - 8/16/2018 6:03:04 AM

Clinical Contracts Manager

Glenmark Pharmaceuticals Inc., USA - Paramus, NJ

Key Responsibilities : Planning & Execution - Facilitate creation and execution of all contract documents (CDAs, Master Services Agreements, Work Orders, Contracts, Change Orders/Amendments, Consultant Agreements, etc.). - Manage the review and negotiation of contract terms and partner with Legal, Finance and other internal stakeholders as needed to finalize. Ensure compliance with require...more

From Glenmark Pharmaceuticals Inc., USA - 8/16/2018 6:03:04 AM

Sr. Technical Analyst

Merck & Co. - West Point, PA

From Merck & Co. - 8/15/2018 6:47:45 AM
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