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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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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

Roles and Responsibilities - Responsible for scale-up and tech transfer of manufacturing processes to pilot-scale operations and to GMP Manufacturing across Phase I/II, Phase III and commercial to both internal and external manufacturing sites - Establish and manage pilot plant operations for scale-up and non-GMP material production - Build a central MSAT function to act as process ...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

Roles and Responsibilities - Lead the Global Drug Safety and Pharmacovigilance function - Have direct managerial responsibilities pertaining to the function as appropriate - Be responsible for oversight of global drug safety processes and drug safety deliverables - Build on the existing Drug Safety and Pharmacovigilance function at Amicus. - Provide detailed, accurate and timely medical...more

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

Manager, CMC Regulatory Affairs

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - Prepare, author, review, coordinate or maintain simple and complex regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports and agency meeting briefing documents in accordance with applicable regulations - Manage all the regulatory submission documents and the associated supporting documents - Coordinate the authoring, review and c...more

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

Manager, Quality Systems Administration and CSV Compliance

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - Experience in QA / Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environments. - Provide QA assessment and approval for GXP computer system changes. - Demonstrates in-depth knowledge of QA systems principles, concepts, industry practices, and standards. - Support a...more

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

Microbiology Manager

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - This role is responsible for overseeing the Quality Control (QC) microbiology testing function in support of testing services of Phase I-III and commercial appropriate Microbiological testing and Environmental Monitoring functions performed at CMO and CLOs. - Provides Microbiological technical QC expertise at site, within and outside of department, in area of speci...more

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

Sr. Director, Biostatistics and Data Management

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - Contributing to the development of study protocols, in particular, the statistically-related sections (e.g. sample size calculations, statistical methodology, and statistical analyses). - Identifying the most appropriate analytical models/methods for clinical studies, and conducting research on statistical methodology, as needed, to accomplish this. - Developing ...more

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

Associate Director, Clinical Research

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - Develop, author and execute on study protocols and amendments by investigating the literature, searching databases and other existing/investigational products, working with key opinion leaders, clinical trial investigators, and internal scientific, pharmacology and regulatory teams. - Review the data generated during the execution of a study to gather a medical und...more

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

Associate Director, Global Labeling

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - Leads efforts to create, modify, and review labeling documents, including core data sheet, prescribing information, patient labeling, and packaging/artwork content for use with attention to competitive positioning - Co-ordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with techn...more

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

Associate Director, Quality Operations and Management

Amicus Therapeutics - Cranbury, NJ

Roles and Responsibilities - Develop and implement quality management strategy and plans, including resources, systems, timescales, and financials to support the organization's annual business plan and long term strategy. - Based upon strategic Program Plans, develop long range plans and high level timelines. - Ensure detailed plans and timing meet strategic intent and achieve critical miles...more

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

Senior Regulatory Affairs Associate

Catalent Pharma Solutions - Swindon, Wiltshire

Position requirements •Experience of working at a similar level within the pharma industry •Experience of CMC Module 3 chemistry manufacturing control regulatory writing •Experience of eCTD software for regulatory writing. •Excellent oral and written communication skills •Excellent organization skills and attention to detail Why Work for Us: Our Vision is to be the worlds most tr...more

From Catalent Pharma Solutions - 4/19/2018 5:45:03 AM

Senior Director, Global Regulatory Affairs Strategy

Covance, Inc. a division of LabCorp® - Maidenhead, 

Education/Qualifications Recommended: An advanced degree with a focus in the sciences is required, an MD or PhD is preferred. Experience Extensive experience of drug development in the Pharma, biotech or CRO industry with a significant amount of experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.

From Covance, Inc. a division of LabCorp® - 4/19/2018 5:44:31 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 marketp...more

From Merck & Co. - 4/19/2018 5:44:22 AM

Senior Specialist, Global QMS, Chapter 5-Technology Transfer and Commercialization

Merck & Co. - Whitehouse Station West, NJ

Education Minimum Requirement: • Degree in Life Sciences, Engineering or related relevant discipline. Required Experience and Skills**: • Minimum of 6-8 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 senior-level ...more

From Merck & Co. - 4/19/2018 5:44:22 AM

Regulatory Scientist

CSL Behring - King of Prussia, PA

Education and Qualifications: A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous. •Regulatory experience in a biotech or plasma protein company is an advantage. • •Understanding of the scientific principles and technical requirements relevant to the development of a pha...more

From CSL Behring - 4/18/2018 5:49:02 AM
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