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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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Counsel- Clinical Medical & Regulatory Job

Novo Nordisk Inc. - Plainsboro, NJ

Attorney, Biology, Biotech, Clinic, Clinical Research, Compliance, Healthcare, Law, Legal, Medical, Medical Research, Pharmaceutical, Pharmacovigilance, Regulatory Affairs, Science

From Novo Nordisk Inc. - 4/25/2018 5:49:39 AM

Associate Director, Global QMS

Merck & Co. - Whitehouse Station West, NJ

Education Minimum Requirement: • BS or MS Degree in Life Sciences, Engineering or related relevant discipline. Required Experience and Skills**: •Minimum of 8 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site/GMP environment in site/global quality, operational excellence and/or project management roles. •Demonstrated sen...more

From Merck & Co. - 4/25/2018 5:47:59 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 candida...more

From Merck & Co. - 4/25/2018 5:47:59 AM

Principal Scientist, PROs (Patient-Reported Outcomes)

Merck & Co. - Upper Gwynedd, PA

Education Minimum Requirement: Doctoral, or Master's in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field Required Experience and Skills: • Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies; • Minimum 5+ years post PhD or 7+ years post Master's degree of combined pharmaceutical industry and/or academic experience ...more

From Merck & Co. - 4/25/2018 5:47:59 AM

Associate Director, Regulatory Information Team

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Typical Accountabilities •Lead strategy implementation efforts to ensure oversight of RIM system compliance •Drive business value and efficiency in the management and delivery of regulatory information. •Interpret xEVMPD/ISO IDMP data governance, business readiness, and process frameworks •Partner with individual system and information owners within Regulatory, IT and associated organizatio...more

From AstraZeneca Pharmaceuticals - 4/25/2018 5:47:35 AM

Regulatory Affairs CMC Senior Manager

Novartis Pharmaceuticals - East Hanover, NJ

Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or English 1.Minimum 4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals 2.Working knowledge/experience in regulatory submission and approval processes for new chemical entities (...more

From Novartis Pharmaceuticals - 4/25/2018 5:46:55 AM

Senior Specialist, Global Pharmacovigilance

Merck & Co. - Madison, NJ

Education Minimum Requirement: DVM/VMD or equivalent Required Experience and Skills: • Minimum 2 years clinical veterinary medical experience • Excellent interpersonal, communication and negotiating skills • Must be able to work effectively as a team member in a highly interactive and collaborative environment Preferred Experience and Skills: • Knowledge of animal healt...more

From Merck & Co. - 4/23/2018 5:43:29 AM

Director, Global Regulatory Affairs CMC (Animal Health)

Merck & Co. - Madison, NJ

Education Minimum Requirement: Bachelor of Science degree in science, engineering, or other relevant field (advanced degree preferred). Required Experience and Skills: • BS with minimum 10 years pharmaceutical experience including at least 5 years in CMC regulatory environment or DVM/PhD with minimum 5 years experience in CMC regulatory environment • Excellent time and project manageme...more

From Merck & Co. - 4/23/2018 5:43:28 AM

Director, Regulatory Affairs - Site CMC (External Manufacturing)

Merck & Co. - West Point, PA

Education: • The candidate must possess a relevant Bachelor's degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences etc.) Required: • A minimum of 10 years of experience in regulatory CMC in a people management role Preferred: • Experience of working at a Pharmaceutical Manufacturing site in a Regulatory, Quality or Technical Role • Ex...more

From Merck & Co. - 4/23/2018 5:43:28 AM

Global Labeling Manager

Novartis Pharmaceuticals - East Hanover, NJ

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred English Minimum 2-3 years experience in global labeling or other regulatory affairs functions, alternatively 5 years experience in related areas of the Pharmaceutical Industry or Health Authorities.

From Novartis Pharmaceuticals - 4/23/2018 5:43:05 AM

Associate II, Labeling Regulatory Affairs

Novartis Pharmaceuticals - Princeton, NJ

Bachelors Degree or equivalent experience A minimum of 3 years of Pharmaceutical Labeling experience required. Must have ability to take and follow directions. Familiarity with FDA Labeling guidelines (21 CFR) required. Must possess excellent communication and organizational skills, be a team player and have a meticulous eye for details. Must be comfortable with PC Programs such as Word, Excel, ...more

From Novartis Pharmaceuticals - 4/23/2018 5:43:05 AM

Director, Tech Transfer and Manufacturing Sciences

Amicus Therapeutics - Cranbury, NJ

Requirements - Ph.D. in Chemical Engineering, Life Sciences or equivalent and at least 10 years' experience (or) BS/ MS with at least 15 years' relevant experience tech transfer of biologics DS and DP biologic manufacturing process support. Additional experience in small molecule manufacturing is a plus. - Demonstrated experience to analyze and summarize manufacturing data to support prod...more

From Amicus Therapeutics - 4/23/2018 5:42:37 AM

Scientist II - (Gaithersburg, MD)

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Main Duties and Responsibilities The position holder would be expected to take a role as a technical project lead with the responsibility for the design and development aspects of new device development projects, working closely with other functions, business areas, external suppliers and consultants.  Manage device aspects of projects to achieve project targets in a timely fashion and to agreed ...more

From AstraZeneca Pharmaceuticals - 4/20/2018 5:50:18 AM

Executive Director, Global Head of Safety and Pharmacovigilance

Amicus Therapeutics - Cranbury, NJ

Requirements - M.D. degree required with at least 8-10 years of pharmaceutical Drug Safety and Pharmacovigilance experience in both the pre- and post-marketing settings, and with global experience. - Strong leadership skills, as well as experience working in a matrix environment. - Advanced ability to read, analyze and interpret safety-related scientific and medical literature - Posses...more

From Amicus Therapeutics - 4/19/2018 12:59:21 PM

Manager, CMC Regulatory Affairs

Amicus Therapeutics - Cranbury, NJ

Requirements - The successful candidate must possess a Bachelor's degree in Pharmacy, Biology, Chemistry or related healthcare functional area - Advanced Scientific or Process Engineering degree is desirable - Regulatory Affairs Certification is preferred - The candidate must have at least 3 years of regulatory experience in the pharmaceutical or biotechnology industry as it pertains t...more

From Amicus Therapeutics - 4/19/2018 12:59:21 PM

Manager, Quality Systems Administration and CSV Compliance

Amicus Therapeutics - Cranbury, NJ

Requirements - Bachelor's Degree in technical discipline or related field with minimum of ten (10) years' related experience. - Must have previous experience and proven track record of validating EDMS, Learning Management and QEM solution, preferably Master Control. - Strong understanding of the current pharmaceutical industry and applicable regulations, with emphasis in 21 CFR Part 11, 2...more

From Amicus Therapeutics - 4/19/2018 12:59:21 PM

Microbiology Manager

Amicus Therapeutics - Cranbury, NJ

Requirements - Bachelor's degree or advanced degree in Microbiology or related discipline. - A minimum of 10-15 years' experience working in a GMP QC Microbiology Laboratory, including significant clean room experience preferably in an aseptic processing facility. At least 2 years of management experience required. - Knowledgeable and/or exposure to biological manufacturing processes incl...more

From Amicus Therapeutics - 4/19/2018 12:59:21 PM

Sr. Director, Biostatistics and Data Management

Amicus Therapeutics - Cranbury, NJ

Requirements - PhD (preferred; minimum 15 years of experience) in Statistics/Biostatistics in the biopharmaceutical industry, with knowledge of biomedical sciences. - Demonstrated expertise in statistical planning, data analysis and reporting of clinical trial data is a must. - Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical metho...more

From Amicus Therapeutics - 4/19/2018 12:59:21 PM

Associate Director, Clinical Research

Amicus Therapeutics - Cranbury, NJ

Requirements - Medical Doctor's (MD) degree is required. - Significant experience practicing medicine is a plus. - A combination of credentials and personal attributes including medical training, clinical practice, industry drug development experience, strong work ethic, and integrity are necessary for success in this role. Specifically, Amicus is seeking: - 2+ years of drug developmen...more

From Amicus Therapeutics - 4/19/2018 12:59:20 PM

Associate Director, Global Labeling

Amicus Therapeutics - Cranbury, NJ

Requirements - BS or MS in scientific discipline or equivalent required. Advanced degree and/or RAC certification preferred - 8-10 years of regulatory affairs experience with drugs and/or biologics; at least 5 years' experience in pre and post market labeling development and review - Extensive knowledge of global regulations, guidance documents, and initiatives related to labeling require...more

From Amicus Therapeutics - 4/19/2018 12:59:20 PM
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