Regulatory Affairs Jobs

Note: APA operates on a 37.5-hour work week with one-hour lunch breaks each day. APA sets salaries based on several considerations, including years of relevant experience, level of education, and previous staff and/or governance experience at APA. The Health Policy and Healthcare Financing Departmen

Overview The Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS programs. The role will lead the regulatory strategy and facilitate submission of data packages to the US. The role is responsible for planning and

Overview Who We Are: At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight

Responsibilities: Authoring regulatory submissions : Writing and reviewing the CMC sections for new e.g. New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) and lifecycle maintenance regulatory filings including responses to Health Authority’s questions. Ensuring regulatory

Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Support for the registration of OTC drugs in EU countries. Support regional RA team to compile submission packages. Prepare cover letter, application for

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and co

Hiive is redefining how private companies and their shareholders access liquidity. Through its institutional-grade platform, Hiive brings together buyers, sellers, and issuers to facilitate secondary transactions in venture-backed, pre-IPO companies, introducing efficiency, transparency, and standar

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast p

Responsibilities: Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval Responsible for reviewing and writing CMC modules 2 and 3 Exposure to EU and CIS region in regulatory filings Herbal product developme

Why should you join dLocal? dLocal enables the biggest companies in the world to collect payments in 40 countries in emerging markets. Global brands rely on us to increase conversion rates and simplify payment expansion effortlessly. As both a payments processor and a merchant of record where we ope

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast p

Join Riverside Natural Foods Ltd., a Canadian-based, family-owned, and globally operating business, committed to leaving the world better than we found it. As a B-Corp certified, Triple-Bottom Line company, we proudly manufacture nutritious, 'better-for-you' snacks such as MadeGood and GOOD TO GO. W

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is a

Director, Regulatory Affairs Advertising & Promotion, US The salary range for this position is between $205k and $240k. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, ski

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Regulatory Affairs on a permanent basis

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapie

⚡️ About Merkle Science Merkle Science provides blockchain transaction monitoring and intelligence solutions for web3 companies, digital asset service providers, financial institutions, law enforcement and government agencies to detect, investigate, and prevent illicit use of cryptocurrencies. Our v

Your work will change lives. Including your own. Please note: Our offices will be closed for our annual Summer Break from Monday, June 29, 2026, through Friday, July 3, 2026. Our response to your application will be delayed. The Impact You’ll Make Recursion is at the forefront of re

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast p

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast p