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MANAGER, REGULATORY AFFAIRS CMC - NOW HIRING

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...

CompanyTakeda Pharmaceutical
AddressBrooklyn, NY
CategoryInformation Technology
Job typeFull-time, Part-time
Date Posted a month ago See detail

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, 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...

a month ago seen See more...

Manager Regulatory Affairs

Philip Morris

Washington, United States

Were totally transforming our business and building our future on one clear purpose to deliver a smoke-free future.In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. Monitors & facilitates...

a month ago seen See more...

Senior Project Manager, Medical Affairs

Astellas

Northbrook, IL

Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration...

a month ago seen See more...

Senior Project Manager, Medical Affairs

Astellas Pharma, Inc.

Northbrook, IL

Lead, create, drive, and ensure effective project management to all aspects of the Core Medical Team (CMT) functioning globally and collaborate with Regional CMT members to ensure effective execution. Works in close collaboration...

a month ago seen See more...

Manager, Regulatory Affairs

Biospace

King Of Prussia, PA

You will plan, direct, and monitor Regulatory Affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce, sell, and distribute its...

a month ago seen See more...

Audit Project Manager - Regulatory Compliance

U.s. Bank National Association

Charlotte, NC

$116,280 - $150,480 a year

Bachelor's degree, or equivalent work experience. Typically more than eight years of applicable experience. Considerable knowledge of applicable laws, regulations, financial services, and regulatory trends that impact their assign...

a month ago seen See more...

Senior Manager, Regulatory Affairs Biocides - Remote

Steris

Alpharetta, GA

Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...

a month ago seen See more...

Manager, CMC Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

West Chester,

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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Manager, Regulatory Affairs

Bausch + Lomb

Remote

$90,000 - $130,000 a year

BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. to analyze impact on Company produc...

2 months ago seen See more...

Regulatory Compliance Project Manager

Qmetrics

California, United States

$31 - $41 an hour

Assist in developing internal and external delegation oversight audit protocols (per the California DMHC rules applicable to commercial health plans and contractual requirements). Perform and co-lead internal and external delegati...

2 months ago seen See more...

Regulatory Affairs Associate Manager

Comtec

Remote

$35 - $43 an hour

Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations. Participate in validation of marketing campaigns and review of associated ma...

2 months ago seen See more...

Regulatory and Corporate Affairs Manager

Hf Sinclair

Dallas, TX

$104K - $131K a year

Closely monitor rulemaking and regulatory changes that could impact the company and/or industry. Highlight potential threats/risk and develop positions for Senior Management and Government Affairs team. Coordinate cross-functional...

2 months ago seen See more...

Senior Manager, Regulatory Affairs

Apellis Pharmaceuticals

Remote

$132K - $167K a year

Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...

2 months ago seen See more...

SENIOR MANAGER REGULATORY AFFAIRS

Tk-Chain Llc

Princeton, NJ

$80,000 - $170,000 a year

Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Must be able to effective articulate c...

2 months ago seen See more...

Manager, Regulatory Affairs

Immunomic Therapeutics, Inc.

Rockville, MD

$140,000 - $160,000 a year

Assists in the development of regulatory strategies and their execution. Coordinates the preparation of documents for INDs and related regulatory submissions including amendments, annual reports, new protocol submissions, protocol...

2 months ago seen See more...

CMC 2 Manager- Regulatory Affairs

Raise In Partnership With Genpact

United States

$103K - $131K a year

Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in...

2 months ago seen See more...

Manager, Regulatory Affairs - Devices

Allergan Aesthetics

Irvine, CA

$125K - $158K a year

Represents US Regulatory in project teams. Develops US regulatory filing strategy, with input from supervisor. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives. Work...

2 months ago seen See more...

Manager, Regulatory Affairs

Rion Inc

Rochester, MN

From $113,018 a year

Bachelors in Science / Masters (Preferred). Regulatory Affairs Experience: Minimum 5 years. Assist in the development, review, and approval of key documents, including abstracts, presentations, protocols for IND and BLA submission...

2 months ago seen See more...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

2 months ago seen See more...

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...

2 months ago seen See more...

Solta Senior Manager, Regulatory Affairs

Solta Medical

Bothell, WA

$120,000 - $180,000 a year

Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product p...

2 months ago seen See more...

Sr. Manager, Regulatory Affairs CMC (Remote)

Ptc Therapeutics

Remote

Leads and manages the development of Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and ar...

2 months ago seen See more...

Manager, Regulatory Affairs

Ascendis Pharma

Palo Alto, CA

$140,000 - $150,000 a year

Today, were advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful diffe...

2 months ago seen See more...

Regional Manager of Quality & Regulatory Affairs

Alaska Dialysis

Alaska, United States

$81.7K - $103K a year

Responsible for overseeing regulatory and growth perspective in accordance with Company goals. Assist in clinical operational development and transition of new or acquired clinic(s) as needed or requested. Assess and integrate cli...

2 months ago seen See more...

Group Manager, Regulatory Affairs

Globus Medical, Inc.

Audubon, PA

$110K - $139K a year

Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval...

2 months ago seen See more...

Senior Manager, Regulatory Affairs - Product Development

Arthrex

Naples, FL

$114K - $145K a year

Develop and implement regulatory strategies for Product Development and continuous improvement projects, ensuring alignment with business objectives and regulatory requirements. Lead assigned team(s) in establishing short-term and...

2 months ago seen See more...

Manager, Regulatory Affairs CMC

Takeda Pharmaceutical

Boston, MA

$133,000 - $209,000 a year

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...

2 months ago seen See more...

Manager - Regulatory Affairs

Jtm Food Group

Harrison, OH

$95.6K - $121K a year

Top Work Place Winner. Weekly Pay. Free Meal Buffet, Discount on JTM Products. Free Uniforms, Shoe Allowance. Free Gym Membership, Free Health Screenings. Full Medical Benefits. 401K/Profit Sharing. Generous PTO. Bonus Potential (...

2 months ago seen See more...

Regulatory Affairs Director: State Prog Admin Manager Prin

State Of Minnesota

Saint Paul, MN

$46.36 - $66.49 an hour

Who May Apply: Open to all qualified job seekers Date Posted: 03/20/2024 Closing Date: 04/09/2024 Hiring Agency/Seniority Unit: Commerce Dept / Commerce-Managerial Division/Unit: Energy Resources / Office of Regulatory Affairs Day...

2 months ago seen See more...

Regulatory Affairs Sr Manager (Medical Device)

Connexion Systems & Engineering, Inc.

Westford, MA

Responsible for the oversight of Regulatory Affairs as directed. Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of in...

2 months ago seen See more...

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