Regulatory Affair Consultant jobs
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SENIOR MANAGER/ASSOCIATE DIRECTOR, REGULATORY AFFAIRS, STRATEGIC GLOBAL LABELING - COMBINATION
Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...
| Company | Biospace |
|---|---|
| Address | North Chicago, IL |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 4 weeks ago See detail |
Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination
Biospace
North Chicago, IL
Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...
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Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH
Abbott Laboratories
Lake Forest, IL
$72,700 - $145,300 a year
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...
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Senior Associate - Regulatory Affairs
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
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Regulatory Affairs Specialist - Labeling
Nesco Resource
Andover, MA
Up to $38.46 •
Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.. Initiates, reviews and a...
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Regulatory Affairs Associate III
Teva Pharmaceuticals
Lorida, FL
Who we areTogether, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Write, review and compile documentation and data necessary for submission of assig...
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Regulatory Affairs Associate - North Chicago, United States - Validation Associates
Validation Associates
United States
As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...
a month ago seen
USA Regulatory Affairs Specialist Project Lead I Scientific
Adecco
Bridgewater, NJ
$ 88 - $ 89.22 / Hour
Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...
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Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite)
Avanos Medical
Alpharetta, GA
401(k)
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;. Making a difference in how we work and collaborate, constantly nurturing our nimble culture of inn...
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Senior Manager, Regulatory Affairs Vendor Governance
Biospace
California, United States
Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...
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Regulatory Affairs Manager (CMC Site)
Biospace
New Albany, OH
Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...
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Associate Manager, Regulatory Affairs (Hybrid)
Iff Family Of Companies
Hazlet, NJ
Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...
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Manager, Global Regulatory Affairs CMC
Biospace
Boston, MA
I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...
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Manager, Regulatory Affairs- North America (Hybrid)
Iff Family Of Companies
Hazlet, NJ
Mentoring and working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulator...
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Manager, CMC Regulatory Affairs - Remote OR West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...
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Associate Director, Regulatory Affairs - Remote OR West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...
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Counsel, Head of Global Regulatory Affairs
An Asset Management Company
Los Angeles, CA
Coordinate TCW's engagement with regulators and other policymakers on Global Regulatory matters, including representing TCW in such engagements. Position TCW to influence policy and regulations; consider TCW's clients and business...
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Regulatory Affairs Specialist I (DePuy Synthes) - Medical Device Business Services, Inc.
Johnson & Johnson
Warsaw, IN
...
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Manager, Regulatory Affairs CMC - Now Hiring
Takeda Pharmaceutical
New York, NY
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...
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Director, Regulatory Affairs
Byheart
New York, NY
The only U.S.-made infant formula to use organic, grass-fed whole milk. The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk-alpha-lac and lactoferrin-to our ingredients list. T...
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Sr. Specialist, Regulatory Affairs CMC
Biospace
United States
Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy. Review and edit final documents for regulatory...
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Sr. Director, Regulatory Affairs
Biospace
San Diego, CA
Develop, implement and maintain regulatory and quality assurance strategies and activities for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Regulatory Affairs Manager - Now Hiring
Abbott Laboratories
Texas, United States
$95000 - $190000 per year
Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...
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