Director of Regulatory Affairs: FDA Submissions & ANDAs
Padagis LLC
A leading generic pharmaceutical company is seeking an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for pharmaceutical products. This pivotal role involves ensuring FDA compliance and guiding products through development. The ideal candidate will have 7–10+ years of experience in Regulatory Affairs and a proven track record of managing ANDA, IND, NDA submissions. This position is remote eligible for candidates in the United States, preferably near Minneapolis-St. Paul, Minnesota. #J-18808-Ljbffr
- ...generic pharmaceutical company is seeking a Director or Associate Director of Regulatory Affairs in Round Lake, Illinois. The role involves... ...regulatory strategies, overseeing submissions, and ensuring compliance with FDA guidelines. Candidates should possess an advanced...SuggestedRemote work
$109.5k
...Instagram ( , X ( and YouTube. ( Job Description The Device Regulatory Affairs Submission Manager is responsible for leading the planning,... ...submissions for medical devices in one or more regions, such as FDA, EU MDR/IVDR, or other international markets. ~ Strong understanding...SuggestedLocal area- AbbVie is seeking a Device Regulatory Affairs Submission Manager responsible for leading the planning, preparation, and submission of regulatory dossiers for medical devices. The ideal candidate has 6+ years of experience in regulatory affairs and a strong understanding...Suggested
- ...experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible... ...regulatory strategies, submission requitements and writing... ...of the submissions are ANDAs for generic products in... ...development pipeline, securing FDA approval, and...SuggestedRemote work
- ...BioSpace is seeking a Manager of Regulatory Affairs to develop and implement regulatory strategies for the U.S. and Canada.... ...of regulatory experience and involves preparation of submissions and compliance with FDA requirements. The position offers a hybrid work schedule...Suggested
- AbbVie seeks a Manager of Regulatory Affairs, responsible for regulatory strategy in the US and Canada for its products. The role includes liaising with FDA, preparing regulatory submissions, and advising on compliance. Qualified candidates will have 6 years of experience...
$109.5k - $208.5k
...Manager Regulatory Affairs, Global Reg Strategy US & Canada The Manager... ...(Senior Manager, Associate Director, Director (Global Regulatory... ...Authority (HA) liaison with FDA for routine communications in... ...preparation and review of regulatory submissions consistent within US and...Temporary workWork at officeImmediate startRemote workMonday to Friday- ...Job Description The Manager Regulatory Affairs, Global Reg Strategy US & Canada... ...(Senior Manager, Associate Director, Director (Global Regulatory... ...Authority liaison with FDA for routine communications in... ...preparation and review of regulatory submissions consistent within U.S. and...Temporary workWork at office
- ...Allergan in North Chicago is seeking a Director of Regulatory Affairs, Device to lead the development of regulatory strategies for injection devices... ...interacting with regulatory agencies, reviewing submissions, and ensuring compliance with regulations. Candidates should...
$160.5k - $305k
...Director Regulatory Affairs, Device AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health... ...issues to support and drive strategy for regulatory submissions, including new applications and amendments, renewals, annual...Work at officeImmediate startRemote workWorldwideMonday to Friday- Job Description The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead collaborates with internal... ..., developing and managing content strategy for regulatory submissions (including INDs/CTAs, amendments, market applications,...Work at office
- A global pharmaceutical company is seeking a Manager for Regulatory Affairs to oversee post-approval changes and ensure compliance with regulatory requirements. You will manage CMC submissions and collaborate with various teams. Qualified candidates should have a BA/BS...
- AbbVie in North Chicago is seeking a Manager for Regulatory Affairs focused on Chemistry Manufacturing and Controls (CMC). In this role,... ...will prepare CMC regulatory strategies, manage regulatory submissions, and represent CMC on product development teams. The ideal...
$160.5k
Overview We are currently seeking a Regulatory Affairs Director to join our growing regulatory team. In... .... Prepare teams for and lead FDA and other Health Authority meetings.... ...in the creation, review, assembly and submission of regulatory documentation including...- ...Job Description The Manager Regulatory Affairs, Global Reg Strategy US & Canada... ...(Senior Manager, Associate Director, Director (Global Regulatory... ...Authority (HA) liaison with FDA for routine communications... ...and review of regulatory submissions consistent within US and Canada...Temporary workWork at office
- ...assist customers with financing options. The role includes managing compliance with all regulations while ensuring accuracy in deal submissions to lenders. Ideal candidates will have significant experience as a Finance Manager, excellent communication skills, and a...
- ...preparing and reviewing classification requests for government submissions, ensuring accuracy and thoroughness. + Proactively review... ...insights by proactively tracking, interpreting, and communicating regulatory and legislative updates to GTC stakeholders-ensuring the...Temporary workLocal areaWorldwide
- ...Facebook, Instagram, X and YouTube. Job Description The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Post Approval... ...and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper...Temporary work
- ...preparing and reviewing classification requests for government submissions, ensuring accuracy and thoroughness. Proactively review... ...insights by proactively tracking, interpreting, and communicating regulatory and legislative updates to GTC stakeholders, ensuring the...Temporary workWorldwide
$182k - $346k
...Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain...Temporary workWork at officeImmediate startRemote workWorldwideMonday to Friday- ...A leading global healthcare company is seeking a Director, Strategic Medical Writer in North Chicago, Illinois. The role involves providing strategic leadership for clinical and regulatory writing projects across therapeutic areas. Candidates should have at least a Bachelor...
$160.5k
...Instagram ( , X ( and YouTube. ( Job Description The Director, Health Economics & Outcomes Research (HEOR) leads... ...-based plans that support global and regional HTA submissions, payer negotiations, and regulatory requirements. Provides product leadership to HEOR...Full timeWork experience placementLocal area$109.5k
...identify root causes, and share actionable insights across international business units. The role reports to the Associate Finance Director, International Marketing - Specialty Products. Major Responsibilities: Lead the development and execution of comprehensive...Local area$100k - $115k
...Job Title: Manager, Regulatory & Trade Compliance Reports To: Director, Regulatory Compliance Location: Vernon Hills, IL Work Type: Hybrid... ...Education: ~ Bachelor's Degree in Regulatory Affairs, Life Sciences, or related field, or equivalent...Work at officeLocal areaRelocation package- ...Job Description Reporting to the Director, MHI Compliance and Independent Education, Medical Review, the Senior Manager is accountable... ...Global Headquarters, Affiliates, therapeutic area teams, Regulatory Affairs, HEOR, OEC, and all functional areas of Medical Affairs +...Local area
- ...Job Description The Associate Director, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities... ..., cross‑functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of...Local area
- ...categories of purchase stability behavior, inventory DOH levels, order fulfillment rates to downstream pharmacy customers and timely submissions/accuracy of product movement data submitted via EDI. Actual performance vs. these defined metrics are computed weekly and...Contract workTemporary workLocal areaFlexible hours
- ...Instagram, X and YouTube. Job Description The Director, Strategic Medical Writer provides... ...and direction for clinical and regulatory writing projects for one large or multiple... ...and communications on writing projects/submissions utilizing cross-functional skills/expertise...
- Allergan is seeking a Manager Regulatory Affairs for Global Regulatory Strategy in North Chicago,... ...markets and serves as a key liaison with the FDA. The ideal candidate has significant... ...you will contribute to regulatory submissions and compliance efforts while enjoying a...
- ...Senior Manager RA, Global Regulatory Strategy US & Canada... ...Lead, Associate Director, or Director. Serve as... ...liaison by coordinating FDA meetings, teleconferences... ..., including Public Affairs, Clinical Development,... ...and review regulatory submissions, ensuring completeness...
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