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SENIOR ASSOCIATE REGULATORY AFFAIRS

Execute the international regulatory strategy and regulatory plans. Prepare supportive documentation for regulatory deliverables. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support...

CompanyBiospace
AddressWashington, DC
CategoryInformation Technology
Job typeFull time
Date Posted a month ago See detail

Senior Associate Regulatory Affairs

Biospace

Washington, DC

Execute the international regulatory strategy and regulatory plans. Prepare supportive documentation for regulatory deliverables. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support...

Associate Director, Regulatory Affairs

American Cybersystems

San Rafael, CA

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022). ClearlyRated Client Diamond Award Winner (2020). One of the Largest Certified MBE Companies in the NMSDC Network...

Associate Manager of North America Regulatory Affairs

International Flavors & Fragrances

Palo Alto, CA

$105.60 - $118.80 an hour

Responsible for overall management of the Animal Nutrition product portfolio. Draft submissions such as US feed GRAS, US AAFCO submissions, and Canadian feed approvals. Serve as the main point of contact for the Animal Nutrition b...

Associate Director / Director, Regulatory Affairs (Generic Medicines)

Cnam - Auditeurs - Accueil

Princeton, NJ

This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. Coordinates, reviews, and may prepare...

Associate Director, Regulatory Affairs

Bausch + Lomb

Bridgewater, NJ

Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes. Responsible for post approval lifec...

Associate Manager, Regulatory Affairs

Kenvue

Skillman, NJ

Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...

Associate Manager, Regulatory Affairs

Johnson & Johnson Consumer Inc.

Skillman, NJ

Understand the Regulatory landscape for Consumer products and effectively manage regulatory priorities and timelines for marketed products and will support regulatory strategy for innovative projects across many regulatory classif...

Associate Director, Regulatory Affairs

Johnson And Johnson

Somerville, NJ

Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....

Associate Director, US Regulatory Affairs Strategy

Daiichi Sankyo, Inc.

Basking Ridge, NJ

Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the...

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...

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...

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...

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...

Associate, Paralegal I- Legal Regulatory Enforcement & Investigations

Bny Mellon

Pittsburgh, PA

$51.7K - $65.4K a year

This is what #LifeAtBNYMellon is all about.In this role, you will make an impact in the following ways:Communicate with regulators and law enforcement agencies.Conduct outreach to various departments and review records in various...

Enterprise Services and Public Affairs, Summer Associate - New York (2024)

Citi

New York, NY

$130,000 a year

Community Investing & Development. Citi Location and Realty Services. Global Communications. Government Affairs. Colleague and Client Services. CRA Regulatory Group. Sustainability and ESG. You have an interest in any of the ESPA...

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...

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...

Global CMC Regulatory Associate, Regulatory Delivery Excellence

Biospace

Indianapolis, IN

Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submissi...

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...

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...

Regulatory Affairs Consultant

Katalyst Healthcares And Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...

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...

Energy Regulatory Associate

An International Law Firm

Washington, DC

Counseling and administrative litigation covering market-based rate, market design, generation interconnection, and transmission issues. Compliance and enforcement matters before FERC, the CFTC, and various exchanges, including in...

Energy Regulatory Associate

An International Law Firm

Austin, TX

Counseling and administrative litigation covering market-based rate, market design, generation interconnection, and transmission issues. Compliance and enforcement matters before FERC, the CFTC, and various exchanges, including in...

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...

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...

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...

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...