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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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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

Global Program Regulatory Manager

Novartis Pharmaceuticals - East Hanover, NJ

Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. English Experience with regulatory submission and approval processes in 1 or more major regions. • Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry. • Experience in HA negotiations. • 2-4 years involvement...more

From Novartis Pharmaceuticals - 2/16/2018 5:49:38 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

Regulatory Information Manager

AstraZeneca Pharmaceuticals - Gaithersburg, MD

Essential Requirements •Minimum 1 year hands-on experience with tracking of regulatory information. •University degree or equivalent experience in life sciences or technical field. •Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals. •Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulat...more

From AstraZeneca Pharmaceuticals - 2/15/2018 5:46:03 AM

Medical Information Specialist

CSL Behring - King of Prussia, PA

Main Responsibilities and Accountabilities: 1. Leads efforts in researching, writing, and reviewing database of accurate, evidence-based, balanced medical information SRLs and FAQs for US and Global Medical Affairs that results in effective communication with our internal and external stakeholders. Establishes and conducts periodic review of current literature for evaluation and inclusion in resp...more

From CSL Behring - 2/14/2018 5:44:13 AM

Director, Vaccines Policy

Merck & Co. - Upper Gwynedd, PA

Education: • Bachelor's degree required. Skills and qualifications: • At least 5 years of demonstrated success working in the public policy arena and/or government • At least 1 year working internationally or in a global context • Knowledge of health and immunization systems • Demonstrated leadership ability to identify strategic priorities, bring together different ...more

From Merck & Co. - 2/14/2018 5:41:54 AM

Biobank Program Manager (NCI)

Leidos Biomedical Research, Inc. - ROCKVILLE, MD

PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: - Experience managing a large network of specimen collection activities - Experience in the ethical, legal, and regulatory aspects of biobanking and human subjects research - Knowledge of best practices in biobanking operations and biobanking data standards - Experience in bios...more

From Leidos Biomedical Research, Inc. - 2/13/2018 5:47:42 AM

Associate II, Regulatory Affairs

Novartis Pharmaceuticals - Wilson, NC

Minimum requirements Bachelor's in a scientific related field required At least three years of pharmaceutical experience required, and at least one year of regulatory experience preferred. Computer knowledge, problem solving skills, strong working knowledge of regulatory and drug development processes, strong technical knowledge, innovative and creative, possesses good judgment and leadership ab...more

From Novartis Pharmaceuticals - 2/12/2018 5:43:52 AM

Director Regulatory Affairs - OTC

Novartis Pharmaceuticals - Fort Worth, TX

Minimum requirements •Bachelors degree in relevant discipline. •English •10 years directly related experience

From Novartis Pharmaceuticals - 2/12/2018 5:43:52 AM

Senior Data Reviewer/Data Reviewer, Office of Data Reliability

Sun Pharma - New Brunswick, NJ

Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field; Master's Degree in Organic Chemistry is desirable. Experience: Minimum 5+ years of experience in a pharmaceutical company in quality assurance/quality control, analytical development and batch record review. Competencies: Technical: Knowledge of strict compliance of approved QC Laboratory testing p...more

From Sun Pharma - 2/9/2018 5:53:41 AM

Documentation Specialist/QC Support (NCI)

Leidos Biomedical Research, Inc. - FREDERICK, MD

PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: - College entry level math skills - Strong oral and written communication skills - Experience in quality assurance or control for technical documents, or similar - Knowledge of File Maker Pro, Study Log, Freezerworks, or similar Expected Competencies: - Strong multitaski...more

From Leidos Biomedical Research, Inc. - 2/9/2018 5:53:23 AM

Investigator, PK Sciences

Novartis Pharmaceuticals - East Hanover, NJ

Minimum requirements Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent. Excellent oral and written communication skills as well as organizational and project management skills will be required. Coaching, mentoring, and people management skills will also essential Investigator: 3+ years of relevant post-doctoral, industry or government experience. Know...more

From Novartis Pharmaceuticals - 2/9/2018 5:52:50 AM
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