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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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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 - 7/23/2018 6:41:23 AM

Clinical Operations Manager

Merck & Co. - Montreal (Kirkland), CA

• Bachelor's Degree (or comparable) in Life Science or equivalent Health Care related experience • Five years clinical research experience • Extensive experience in clinical research operations and experience with project management and coordination • Expertise in core clinical, and regulatory • Extensive knowledge of local regulatory environment and submission and appr...more

From Merck & Co. - 7/20/2018 6:25:06 AM

Regulatory Global Therapeutic Area Lead

Novartis Pharmaceuticals - East Hanover, NJ

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Fluency in English as a business language. Additional language is an asset. •Minimum 8-10 years development experience in pharmaceutical industry and minimum 5 years relevant regulatory experience which includes the following: •GPRD or equivalent experience on multiple/comple...more

From Novartis Pharmaceuticals - 7/20/2018 6:24:31 AM

Quality Operations Lead - ASPEX

Novartis Pharmaceuticals - Fort Worth, TX

Bachelor's Degree or equivalent years of directly related experience The ability to fluently read, write, understand and communicate in English 10 Years of Relevant Experience 6 Years of Demonstrated Leadership

From Novartis Pharmaceuticals - 7/19/2018 6:41:04 AM

Distinguished Scientist, Vaccine Process Science Expert

Merck & Co. - West Point, PA

Education and Work Experience Requirements: • Required: Ph.D. in Science with a minimum of (15) years broad experience in Vaccine Process Science Required Experience: • Courage with Decisiveness to Act: Bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to the execution and a drive towards impact and outcome • Track record of sustained ext...more

From Merck & Co. - 7/19/2018 6:40:48 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 - 7/18/2018 6:37:47 AM

Clinical Project Manager (NCI)

Leidos Biomedical Research, Inc. - ROCKVILLE, MD

Qualifications: BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: - Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a clinical, biological/biomedical science or healthcare related field. (Additional qualifying exp...more

From Leidos Biomedical Research, Inc. - 7/17/2018 6:42:27 AM

Manager, Regulatory Affairs

Amicus Therapeutics - Cranbury, NJ

QUALIFICATIONS AND BACKGROUND REQUIREMENTS - Bachelor's or Master's degree in a scientific discipline or equivalent. Regulatory Affairs Certification is preferred - Candidate must possess at least 3 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility. - Experience working with innovative products...more

From Amicus Therapeutics - 7/16/2018 6:32:08 AM

Regulatory Submissions Manager

Amicus Therapeutics - Cranbury, NJ

QUALIFICATIONS AND BACKGROUND REQUIREMENTS - BS or MS in scientific discipline or equivalent required. Project Management certification (i.e. PMP) and/or RAC certification preferred. - 3-8 years of regulatory affairs experience with drugs and/or biologics; at least 2 years' experience in regulatory submissions management; at least 1-2 years' experience in global markets. - Experience...more

From Amicus Therapeutics - 7/16/2018 6:32:08 AM

Director, Liaison, Vaccine/Infectious Disease Regulatory

Merck & Co. - Rahway, NJ

Education: •M.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline required. M.S. (see below). Required: •M.D. with minimum of 5 years drug development or clinical experience; PhD or other related doctoral degree with minimum of 7 years relevant drug development experience required. M.S. or comparable degree in health professions with minimum o...more

From Merck & Co. - 7/16/2018 6:31:20 AM

Regulatory Content Source Management Analyst

Merck & Co. - Upper Gwynedd, PA

Education Minimum Requirement: Bachelor's or master's degree in a life science/health care/pharmaceutical or technology related field Required Experience and Skills: • 5+ years of industry experience, preferably in a regulatory/compliance industry utilizing content management systems • Experience with enterprise content management using at least one industry-leading technologies (e.g, EMC/Doc...more

From Merck & Co. - 7/16/2018 6:31:20 AM

Senior Specialist, Quality Assurance

Merck & Co. - West Point, PA

Education Minimum Requirement: B.A., B.S., M.S. and/or Ph.D. degree in an appropriate Science or Engineering discipline. Required Experience and Skills: Minimum of five (5) years' experience with B.S. or three (3) years with M.S. Experience should be in the pharmaceutical/biotechnology industry. Demonstrated analytical, problem-solving and communication (oral/written) skills are required. A work...more

From Merck & Co. - 7/16/2018 6:31:20 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 - 7/16/2018 6:31:05 AM

Sr Assoc Drug Safety

Covance, Inc. a division of LabCorp® - Dalian, Liaoning Province

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 reside...more

From Covance, Inc. a division of LabCorp® - 7/13/2018 6:38:57 AM

Senior Specialist, Sales Forecasting & Demand Planning (Temporary)

Merck & Co. - Montreal (Kirkland), Quebec

• Education: Bachelor's degree with a preference in Business or Science (MBA an asset). • Experience: Minimum of five years of related work experience, preferably in the pharmaceutical industry in the areas of forecasting/planning/analytics. Experience working in SAP and/or GMP environment would be an asset. • Very high attention to details with ability to rapidly manipulate l...more

From Merck & Co. - 7/13/2018 6:38:31 AM

Director, Liaison, Vaccine/Infectious Disease Regulatory

Merck & Co. - Rahway, NJ

Education Minimum Requirement: M.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline required. M.S. (see below). Required Experience and Skills: M.D. with minimum of 5 years drug development or clinical experience; PhD or other related doctoral degree with minimum of 7 years relevant drug development experience required. M.S. or comparable degree in h...more

From Merck & Co. - 7/12/2018 6:42:04 AM

Director Sr Legal Counsel Vision Care

Novartis Pharmaceuticals - Fort Worth, TX

•Bachelor of Law/Juris Doctorate •Fluent in English •Minimum 6 years post Bar experience required, ideally of which a minimum of 3 years industry experience within a healthcare, pharmaceutical or medical device environment (either counseling as external counsel at top tier law firm or in-house). •Significant experience drafting, negotiating, reviewing and counseling on commercial transaction...more

From Novartis Pharmaceuticals - 7/11/2018 6:43:33 AM

Executive Director, Regulatory Affairs CMC PCV Franchise

Merck & Co. - West Point, PA

Skills: • Develop and maintain expert knowledge of current global regulatory CMC requirements for investigational submissions, original registrations and post-approval changes. This includes knowledge of the regulatory guidance for bacterial polysaccharide conjugate vaccines. • Identify and resolve technical and operational problems associated with regulatory strategy and submissions using ...more

From Merck & Co. - 7/11/2018 6:43:10 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. - 7/10/2018 6:31:43 AM

AD Regulatory Affairs, Oncology

Novartis Pharmaceuticals - Cambridge, MA

Candidate must have a Master's or foreign equivalent degree in, Regulatory Affairs, Pharmacy or Life Science field and a minimum of 2 years' experience in regulatory compliance and drug development activities spanning early development up to post-marketing. Must have experience in: oncology regulatory affairs; reviewing and analyzing regulatory implications of efficacy and safety data; providing s...more

From Novartis Pharmaceuticals - 7/10/2018 6:31:26 AM
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