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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 Project Manager

CSL Behring - King of Prussia, PA

Education Required:   A university degree in Science, Allied Health or Engineering. Preferred:   An advanced degree (MSc, PhD) in Science, Allied Health or Engineering, PMP certification, Masters of Business Administration (MBA) or equivalent. Experience Essential Experience : • Greater than five years experience in the biotechnology or pharmaceutical industry (or where relevant a biome...more

From CSL Behring - 2/23/2018 5:45:29 AM

Quality Specialist, QSIP

Merck & Co. - Durham-RTP, NC

Education: B.S., B.A. degree in Science, Engineering, Business or Humanities Required: • A minimum of 5 years of leadership experience including a minimum of 4 years in GMP environment • Understanding of FDA regulations/guidance • Experience with improvement processes • Strong analytical and problem solving skills • Effective communication skills (both written and oral) • Strong custome...more

From Merck & Co. - 2/23/2018 5:43:58 AM

Regulatory Process Lead

Merck & Co. - Upper Gwynedd, PA

Education: • Bachelor's degree with 8 years of industry experience, with 4 years in a Regulatory area and experience with technical systems in a regulated environment OR Master's Degree and a minimum of 6 years of industry experience, with 3 years in a Regulatory area and experience with technical systems in a regulated environment. Required: • Broad range of knowledge of regulatory processe...more

From Merck & Co. - 2/23/2018 5:43:58 AM

Senior Regulatory Affairs Associate

Catalent Pharma Solutions - Braeside, Victoria

•Experience working in a GMP environment •Proven experience in Pharmaceuticals with accountability for compliance and/or regulatory affairs •Demonstrated experience working with CTD format information (experience in writing bioequivalence justifications/biowaivers would be an advantage) •Demonstrated competency using actual or like IT systems such as; eCTD Manager, Manage, ComplianceWire and...more

From Catalent Pharma Solutions - 2/22/2018 5:47:19 AM

Information Center, Quality Assurance Specialist

AstraZeneca Pharmaceuticals - Wilmington, DE

Main Duties and Responsibilities You will be responsible for performing the tasks of the US product quality complaint (PQC) process to ensure consistent, clear, effective, and timely identification and communication of all PQCs to the appropriate investigation supply sites. Understand and support the PQC processes of external customers. Integrate across the organization by developing and maint...more

From AstraZeneca Pharmaceuticals - 2/22/2018 5:46:04 AM

Associate Director - Quality Assurance

Merck & Co. - West Point, PA

Minimum requirement: • B.S or M.S. in Scientific or Engineering field or equivalent experience in the pharmaceutical industry • Minimum 8 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to ...more

From Merck & Co. - 2/22/2018 5:45:46 AM

Global Regulatory Lead, Director 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. - 2/22/2018 5:45:46 AM

Associate Director Market Access Strategy Job

Novo Nordisk Inc. - Plainsboro, NJ

Compliance, Consulting, Diabetes, Field Sales, Government, Governmental Affairs, Healthcare, Law, Legal, MBA, Management, Manager, Medical, Pharmaceutical, Pharmaceutical Sales, Project Manager, Public Policy, Regulatory Affairs, Research, Retail, Retail Sales, Sales, Science, Special Medicine, Strategy, Technology

From Novo Nordisk Inc. - 2/21/2018 5:44:00 AM

Senior Dir Vendor Mgt

Covance, Inc. a division of LabCorp® - Princeton, NJ

Education/Qualifications Required University/College Degree (preferably postgraduate degree) Preferred - An understanding of global drug development and the clinical trial process - An understanding of aspects surrounding Covance business development (time and cost estimates, bid defense, contracts) - An understanding of Covance procedures, including Standard Operating Procedures ...more

From Covance, Inc. a division of LabCorp® - 2/21/2018 5:42:02 AM

Associate Director, Regulatory Affairs

Merck & Co. - Rahway, NJ

Education: •Bachelor's Degree with a minimum of 10 years of regulatory related experience or an advanced degree and a minimum of 8 years of regulatory related experience Required: •Must have a working knowledge of the processes, systems, and business requirements within Regulatory Affairs and/or CMC as it relates to product development, manufacturing, registration, post-marketing activit...more

From Merck & Co. - 2/21/2018 5:41:48 AM

Quality Complaints Specialist

Catalent Pharma Solutions - Winchester, KY

The Role •Primary internal quality contact for all Customer Complaints received.  The qualified individual is expected to become the Subject Matter Expert for the process. •Responsible for supporting parts of internal, client and regulatory audits that are related to Customer Complaints System. •Responsible for trending procedures that monitor the health of the Customer Complaint System....more

From Catalent Pharma Solutions - 2/20/2018 7:01:39 AM

Senior Regulator Affairs Specialist

Catalent Pharma Solutions - St. Petersburg, FL

The Role (daily responsibilities) •Preparation and submission of ANDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required •Prepare and submit all federal, s...more

From Catalent Pharma Solutions - 2/20/2018 7:01:39 AM

Sr Regulatory Affairs Specialist

Novartis Pharmaceuticals - Houston, TX

Minimum requirements Education requirements •Minimum: B.S. Degree •English Experience Requirements •Minimum: 2 years of relevant experience

From Novartis Pharmaceuticals - 2/20/2018 6:59:43 AM

Finance - Clinical Operations Manager (COM)

Merck & Co. - Montreal (Kirkland), CA

•Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience •Five to seven years clinical research experience •Extensive experience in clinical project management and coordination •Expertise in core clinical, regulatory and financial systems, tools and metrics •Extensive knowledge of local regulatory environment and subm...more

From Merck & Co. - 2/20/2018 6:59:23 AM

Director, Regulatory Affairs - Companion Diagnostics Lead

Merck & Co. - Rahway, NJ

Education: • Required:Bachelor's degree • Preferred: M.S., PharmD., or PhD in biological science, chemistry, engineering or related discipline Required Experience and Skills: • A minimum of 5 years of relevant regulatory experience in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs. • Demonstrated scientific knowledge, writing ability...more

From Merck & Co. - 2/20/2018 6:59:22 AM

Senior Clinical Scientist

CSL Behring - King of Prussia, PA

Requirements: Ph.D or MS in life sciences with some previous experience in clinical research or BS with at least 3 years of clinical development experience.  The ability to work cross-functionally is essential.    Excellent communication skills, oral and written, are required.  Strong knowledge of clinical research and the drug development process required. Proven ability to work independentl...more

From CSL Behring - 2/19/2018 6:37:30 AM

Clinical Scientist

Merck & Co. - Rahway, NJ

Education: •Degree in the Life Sciences •Bachelor's degree with 4+ years'; or MS with 3+ years' relevant career experience Required: •Pharmaceutical and/or clinical drug development experience •Understanding of clinical research process from clinical program/trial planning to regulatory submission •Demonstrated oral and written communication and computer/database management ...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Director, Translational Pharmacology, Neuroscience

Merck & Co. - Rahway, NJ

Education: • MD or MD/PhD OR PhD with at least 10 years of drug development experience to include preclinical pharmacology, biomarker validation and development, and team management Required: • Proven track record in clinical medicine or clinical research, and background in neuroscience research. • Demonstrated record of scientific scholarship and achievement in neuroscience research, tran...more

From Merck & Co. - 2/19/2018 6:35:37 AM

Manager, Maintenance (Millsboro, DE)

Merck & Co. - Millsboro, DE

Education: Associate’s degree in Engineering or other Scientific/Technical Area OR Master’s License in Trade (Electrical, HVAC, HVAC/R, Plumbing, etc.) Required: • A minimum of 8 years’ industry experience as an engineer, supervisor, or technical lead in a maintenance department that supports a manufacturing setting. • 3 year’s management and or lead role experience (people/budget/or...more

From Merck & Co. - 2/16/2018 5:49:54 AM

Team Lead - Medical Safety Review

Merck & Co. - Rahway, NJ

Education: • M.D. or D.O. and equivalent Required: • Minimum of 3 years clinical practice experience, following training or prior industry experience in safety, clinical development and/or medical affairs • Relevant Safety Systems Experience (i.e. Argus, ARIS-G, etc). • Minimum 3 years People Management Experience • Minimum of 8 years of professional experience and/or pharmaceutical in...more

From Merck & Co. - 2/15/2018 5:46:44 AM
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