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Regulatory Affairs Associate Jobs

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The Manager/Sr. Manager position is office or home based with -30% travel to the Pittsburgh, PA area. This position manages Regulatory Affairs Associates and Specialists. Provides regulatory advice on strategy and manage projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. *LI-LC1 Education...

Labeling Support Specialist (Contract) - Thousand Oaks, CA Experis is hiring for a Labeling Support Specialist to oversee the process for providing quality drug product regional labeling for health authority submissions that reflect regulatory standards and key stakeholder contributions and perspectives. Job Description: The Regional Labeling Support Specialist is knowledgeable in Labeling Regu...

Overview This position is responsible for the supervision/preparation and critical review of high quality regulatory submissions to the FDA including ANDAs, NDAs, amendments, supplements and annual reports. The Associate Director evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to the Director. The Associate Director will establish ...

Kelly Engineering Resources is currently accepting resumes for an Associate Regulator Affairs Engineer position in Pittsburgh, PA. This is a direct hire position. This position will be responsible for the preparation and submission of domestic regulatory applications for a class 3 PMA medical device including IDEs, PMAs, PMA Supplements, and Annual Reports. This position will be responsible for i...

Job Summary Responsible for assisting the team with regulatory filings as necessary to market Client's products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an understanding of Client's products and their use as well as an understanding of the regulatory admissions process. May perform some or all of the following ...

Regulatory Associate II Job Requirements: - Bachelor’s degree in a scientific discipline - Minimum 3 years pharmaceutical industry experience and a minimum of 2 years regulatory affairs experience and/or quality control or R&D experience in the pharmaceutical industry. Experience in generic regulatory affairs preferred. Position Description: - Assist with responses to FDA deficiencies (CRLs, ...

Regulatory Affairs Associate III: Ortho-Clinical Diagnostics, Inc. is seeking a Regulatory Affairs Associate III for our Raritan, New Jersey location to provide domestic and international regulatory support for the Ortho-Clinical Diagnostics franchise, with a focus on the Asia/Pacific region. Position to determine strategies to obtain appropriate approvals and registrations, and prepare complex su...

Job Title Regulatory Affairs Associate Work Location 3200 Lakeside Drive, Santa Clara CA 95054 Duration 3 months+ Job Description: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements...

Microline Surgical develops and manufactures high precision open and laparoscopic surgical instruments. Microline’s laparoscopic reposable instruments provide a cost-effective, eco-friendly solution for today’s OR. The MiFusion product line offers a broad spectrum of open and laparoscopic instruments used to seal and divide tissue utilizing proprietary thermal fusion technology. JOB SUMMARY: Und...

Microline Surgical develops and manufactures high precision open and laparoscopic surgical instruments. Microline’s laparoscopic reposable instruments provide a cost-effective, eco-friendly solution for today’s OR. The MiFusion product line offers a broad spectrum of open and laparoscopic instruments used to seal and divide tissue utilizing proprietary thermal fusion technology. JOB SUMMARY: Wor...

REGULATORY AFFAIRS ASSOCIATE REQUIREMENT #15-01069 RECRUITER: TROY SANDERS JOB LOCATION: GAITHERSBURG, MD JULY 30, 2015 *** CANDIDATES MUST BE ABLE TO WORK ON OUR PAYROLL AS A W-2 *** Project Description: The Regulatory Affairs Associate is responsible for providing support in the collection, evaluation, preparation, and assembly of Chemistry, Manufacturing, and Control documentation require...

JOB POSTING – BRECKENRIDGE PHARMACEUTICAL, INC. SENIOR REGULATORY AFFAIRS ASSOCIATE This position supports the Regulatory Affairs Manager in day to day activities to ensure the timely compilation and submission of ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA. Location: Berlin, CT Job Responsibilities Include: Review technical/regu...

Kelly Clinical Research is seeking a Regulatory Affairs Associate for a contract opportunity in Round Lake, IL. Under general supervision, The Regulatory Affairs Associate is responsible for the coordination and the preparation of documents/packages for regulatory submissions. They need to have a working knowledge of publishing standards, electronic publishing/viewing tools, and electronic documen...

Awarded the industry's top honors every year since 1994, Davalyn Corporation is one of the most reliable names in the recruiting industry. Founder Richard K. Sinay opened the company's doors on December 18, 1989 and has since become a model to offices nationwide emphasizing the important principles of professionalism, hard work, and accurate representation in creating lasting client partnerships. ...

Regulatory Affairs Level 1 Bergen County Job Function: Responsible for reviewing and approving product labels and claims for accuracy and regulatory compliance on cosmetic, drug, and surface disinfectant products. Contribute to the registration of new products as well as the maintenance of regulatory compliance for approved products during the post-marketing phase. Will assist in preparing quali...

Regulatory Affairs Associate Requirements: -BS or MS degree in a scientific field such as Pharmacy, Chemistry, Biology, etc. -2 years in Regulatory Affairs, in generic Pharmaceutical Industry, or 2-4 years’ exposure in Pharmaceutical field such as Analytical, Products Development or Manufacturing Responsibilities: - Preparation of ANDAs, Supplements, Annual Reports and responses to FDA review...

Company Confidential
THE POSITION OVERVIEW Seeking a Regulatory Affairs Associate I to join the Regulatory Affairs Team. This position will support the Manager of Regulatory Affairs with activities necessary for general regulatory maintenance / surveillance of products in a timely manner. RESPONSIBILITIES · Coordinating and completing stability program reports. · Maintaining the proof-of-life stability reports dat...

Epic Pharma is a generic pharmaceutical company located in Laurelton (Queens) NY. We are dedicated to developing and manufacturing generic prescription drugs in a variety of therapeutic categories in tablet, capsule and powder forms, with a focus on hard to manufacture orally administered drugs in immediate release, sustained release and delayed release forms. We are conveniently located off the B...

Description Endo International plc is a global specialty healthcare company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets, and distributes quality branded pharmaceutical, generic and device products through its operating companies. Endo has global headquarters in Dublin, Ireland and US headquarters in Malvern, PA. Learn more at www.end...

Seeking individual well versed in regulatory guidelines, legal requirements and pending litigations governing Medical Affairs personnel during interactions with healthcare professionals, payor organizations and patient representatives to develop and initiate a comprehensive program to ensure all Medical Affairs employees are provided up-to-date training on compliance, SOPs, and Best Practices. Sh...