Head of Regulatory Affairs

Job Description Summary Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and...

Our premier client is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Reporting to the Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. This position offers the opportunity for you to further develop a career in the...

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...

At MannKind, our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.Position Summary: MannKind Corporation is currently...

Position Title: Head of Regulatory CMC Company Overview: Stirling Q&R is seeking a dynamic and experienced Head of Regulatory CMC (Chemistry, Manufacturing, and Controls) to lead our regulatory efforts in ensuring compliance with CMC requirements for our pharmaceutical and biotech products. This strategic role will play a key part in bridging the gap between...

What You Need to Know About Regulatory Affairs Specialist Example of Regulatory Affairs Specialist Job: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies. Regulatory Affairs Specialist Responsibilities...

*Application is now closed for this role, please view other opportunities or submit your CV in the form below. We are working with one of the world’s most prominent providers of smart logistics solutions. Our client is responsible for 10% of the world’s logistical movement across the globe. They prioritise the most efficient and industry leading...

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...

SUMMARY OF POSITION Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include: Original 505(b)(2)s, pINDs, INDs, Meeting requests, ANDAs, Amendments, Supplements, Annual Reports, and other life cycle management activities. Works with...

Company Location: Bay AreaComp: 150K-220KPosition Reports to: VP of Regulatory and Quality Director of Regulatory Affairs - San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop...

Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the...

Regulatory Affairs CoordinatorCity: FriscoState: TexasZip: 75034CornerStone Professional Placement has partnered with a reputable medical device manufacturing client seeking a Regulatory Affairs Coordinator. As the Regulatory Affairs Coordinator, you will be responsible for assisting the Regulatory Affairs team with gathering and organizing documents for...

Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Job Description The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area. Primary activities include, but are not limited to: ...

Manager, Regulatory Affairs Date: Sep 24, 2024 Location: Lakewood, CO, US Requisition ID:  32768 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Position OverviewOur client, an innovative biopharma company, seeks a Director of Regulatory Affairs to drive regulatory strategy for their anti-infective portfolio through all development phases. This role involves co-leading a US NDA with a cross-functional project team and serving as the FDA liaison. Working remotely from the US with international teams,...

Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.The role:The Director of Regulatory Affairs will be...

Director, Regulatory Affairs CMC Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...