Regulatory Affairs Manager Jobs

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1000+ Regulatory Affairs Manager jobs found on Monster.

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Our client in South San Francisco is looking for a Regulatory Affairs Manager / Sr. Regulatory Affairs Manager to join their team! Duties: Independently coordinates and prepares INDs and, if required, international submissions, including original applications (IMPDs, CTAs) and amendments/supplements. Provide high quality submissions, including consistent terminology, formatting and spelling, and...
Since its inception over 20 years ago in scenic Moab, Utah, The Synergy Company has grown in stature to become one of the most highly regarded brands of certified organic dietary supplements in the international marketplace. Growth of the branded product line has created this dynamic and exciting career opportunity. The Regulatory Affairs Manager (RAM) is responsible for The Synergy Company cGMP ...
Description CSC has an immediate position for a Regulatory Affairs Manager to support Dynport Vaccine Company (DVC). The RA Manager develops the regulatory strategy for products through to licensure, performs scientific and regulatory review of materials for IND applications and amendments and interfaces with Clinical, Nonclinical, Manufacturing and Quality personnel to ensure timely submission o...
Regulatory Affairs – Medical Device – 5 FIGURE SIGN-ON BONUS PAID!, Associate thru Manager level for Medical Device 510k submissions. World leader in their growing market, expanding Regulatory team, lots of advancement for the motivated. Five positions available in the Northeast, USA. Live in one of the world’s leading innovative hotbeds with a variety of lifestyle choices, cultural and outdoors a...
Manager/Sr. Manager, Regulatory Affairs CMC & Operations (Needham, MA) Overview: Celldex is looking for a candidate to manage regulatory CMC aspects of Celldex therapeutic development programs, in collaboration with regulatory product leaders. Responsibility includes authoring and reviewing CMC sections in regulatory submissions. This person will also manage regulatory submissions and applicatio...
Overview: Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our u...
Overview: Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our u...
Senior Project Manager-Regulatory Affairsneeded for acontractopportunity with Yoh's client located inEmeryville, CA. What You'll Be Doing: - Manage the Rebranding program activities to assure successful label content development for products within assigned area and be able to assess impact. - Identify and manage cross-regional rebranding requirements. Consolidate project plans to assess resour...
Job Title: Regulatory Affairs Manager Position Description An exciting leadership opportunity for an experienced Regulatory Affairs Manager is currently available at our client's pharmaceutical facilities located in the Minneapolis, Minnesota area. This leadership role will manage a team of four to seven regulatory professionals. In addition to managing the team, the RA Manager will also oversee...
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we l...
REGULATORY AFFAIRS MANAGER REQUIREMENT #15-00056 RECRUITER: MICHELLE ASHEN JOB LOCATION: GAITHERSBURG, MD MARCH 11, 2015 *** CANDIDATES MUST BE ABLE TO WORK ON OUR PAYROLL AS A W-2 *** THIS POSITION CAN BE DONE REMOTELY Project Description: Prepare, agree and execute regulatory operational plans for allocated projects/products. Contribute to regulatory strategies and provide solutions to r...
Life-changers work here At CareFusion, we create innovative ways to help our customers improve patient care. We rely on bold and inspired employees who share our commitment to helping solve some of healthcare's most critical challenges. CareFusion is now part of Becton Dickinson, a global medical technology company focused on addressing many of the world’s most pressing and evolving health needs...
Requisition ID: 11161 Title: Project Manager - Regulatory Affairs Division: Arthrex, Inc. (US01) Location: INC- Naples, FL (US08) Main Objective: Generates and manages submission documents for new products or changes to existing regulatory filings. Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products. Acts as a liason between ...
Requisition ID: 10841 Title: Project Manager - Regulatory Affairs Division: Arthrex, Inc. (US01) Location: INC- Naples, FL (US08) Main Objective: Generates and manages submission documents for new products or changes to existing regulatory filings. Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products. Acts as a liaison with in...
Regulatory Affairs Manager Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development. Develop regul...
SUMMARY This position manages Regulatory Affairs activities within Medefil, functioning as an independent and objective body that reviews and evaluates regulatory issues/concerns. The position ensures the management and employees are in compliance with the rules and regulations of all regulatory agencies and that company policies and standard operating procedures are appropriate and are being fol...
Our client is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets innovative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years, they have expanded beyond the traditional European base, with over 5,000 employees worldwide, it operates subsid...
Position Summary The primary responsibility of the Senior Regulatory Affairs Manager is to provide regulatory expertise and guidance on Actelion advertising and promotion to ensure compliance with applicable regulations and guidances. Primary Responsibilities Provide regulatory expertise and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, i...
Responsibilities: Acting as a Project Manager for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets: successful regulatory approvals; Optimum market access; Maintenance of produ...
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we l...

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