Head Of Regulatory Affairs

Head of Regulatory Affairs About the Company Innovative biotechnology (BioTech) portfolio IndustryBiotechnology TypePrivately Held About the Role The Company is in search of a Head of Regulatory Affairs to take on a pivotal role in leading strategic regulatory decisions for its innovative biotech portfolio. The successful candidate will be a core member of...

Head of Global Labelling, Regulatory Affairs About the Company Well-established pharmaceutical company IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a Head of Global Labelling in Regulatory Affairs to join their team. This senior leadership role is pivotal in providing expert regulatory knowledge and strategy for 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...

Job Title: Head of Regulatory Affairs-CMCJob Summary:Ironwood Pharmaceuticals seeks a seasoned Regulatory Affairs expert to lead our CMC function, ensuring compliance with global health authority regulations and guidelines. As Head of Regulatory Affairs-CMC, you will develop and execute a strategic regulatory plan to support product development and...

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...

Head of US Regulatory Advertising Promotion & Labeling About the Company Innovative biopharma company IndustryBiotechnology TypePrivately Held About the Role The Company is seeking a Head of US Regulatory Advertising Promotion and Labeling. This pivotal role is responsible for the review, approval, and submission of US promotional materials, as well as...

Head of Compliance About the Company Fast-growing venture builder with a global presence IndustryVenture Capital & Private Equity TypeVenture Capital Firm About the Role The Company is in search of a Head of Compliance to take a leading role in ensuring adherence to regulatory requirements and industry standards. The successful candidate will be responsible...

Vice President, Regulatory Affairs About the Company Excelling biotechnology (BioTech) company IndustryBiotechnology TypePrivately Held Founded2017 Employees201-500 Categories BiotechnologyB2BHealth CareMedicalTherapeuticsPharmaceuticalsMedicineManufacturingChemical Products Specialties cancerpharmaceutical researchfunctional genomicsdrug discoveryand...

Vice President Regulatory Affairs About the Company Pioneering biopharma company IndustryPharmaceuticals TypePrivately Held About the Role The Company is seeking a VP of Regulatory Affairs to take on a pivotal leadership role in shaping the future of the organization. The successful candidate will be responsible for leading the development and execution of...

About the JobThe Senior Specialist, Regulatory Affairs will play a key role in supporting the regulatory submissions process by developing regulatory strategy and submitting materials to health authorities, such as the FDA, for the approval of novel platforms. This position will provide regulatory guidance to internal development teams and prepare document...

About the Job The Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment options for...

Job Title: Associate Director, Global Regulatory AffairsTakeda Development Center Americas, Inc. is seeking an experienced professional to fill the role of Associate Director, Global Regulatory Affairs in Cambridge, MA.Responsibilities:Lead the development of high-level global regulatory strategies for late-stage development projects.Provide global...

Job Summary: We are seeking a highly skilled Senior Manager to lead our Regulatory Affairs team in the development and implementation of regulatory strategies for diagnostic products. The ideal candidate will have a strong background in regulatory affairs, with experience in managing complex projects and developing regulatory strategies for medical devices...

Position Summary This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity...

Company Overview Tango Therapeutics is a biotechnologycompanydedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

About the RoleThe Senior Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, developing regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer...

Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles IndustryRetail TypePrivately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA interactions and...

Job SummaryRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize...

About the Job The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through the development of regulatory strategy and submission of materials to health authorities such as FDA for the approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares...

Key Responsibilities:As a Vice President, Regulatory Affairs, you will lead the development of innovative global regulatory strategies for Tango Therapeutics. This includes preparing and submitting high-quality sections of briefing documents, INDs, CTAs, and BLAs/MAAs in close collaboration with Nonclinical, CMC, Quality, and Clinical teams. You will also...