Remote Regulatory Affairs Manager - Biotech Submissions
$135k - $150kJade Biosciences
- Remote job
Jade Biosciences is hiring a Regulatory Affairs Manager to support regulatory strategies for their clinical-stage therapies. This remote position requires timely submissions and compliance with FDA regulations. Candidates should have extensive experience in regulatory affairs within the biotech industry. The position offers a competitive salary range of $135,000 – $150,000, depending on experience and location. Strong organizational and communication skills are essential, alongside a Bachelor's degree and several years of R&D experience. #J-18808-Ljbffr Jade Biosciences
$135k - $150k
...Biosciences is looking for a Regulatory Affairs Manager to support the execution of regulatory strategies in a remote position. Responsibilities include managing submissions and ensuring compliance with... ...candidate will have 5-8+ years in biotech R&D, strong regulatory...Remote job- A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development...Remote job
- ...Therapeutics in Massachusetts is seeking a Manager/Senior Manager, Regulatory Affairs to drive key regulatory activities... ...involves supporting the timely submission and approval of regulatory... ...regulatory affairs experience in biotech or pharma, a Bachelor’s degree, and...Suggested
$285k - $320k
...a “moneyball for biotech” approach, pooling... ...You'll Do Lead CMC regulatory strategy and execution... ...high‑quality submissions aligned with global... ..., and potentially manage team members as organizational... ...is a U.S.-based remote role that will... ...Regulatory Affairs CMC experience within...Remote workWork at officeFlexible hours- BioSpace is seeking a Regulatory Writing Senior Manager in Washington D.C. to author and oversee regulatory submissions for product approvals. The candidate will lead writing activities and mentor junior writers while ensuring compliance with regulatory standards. Applicants...Remote job
$285k - $320k
...is hiring for a CMC Regulatory Lead in San Francisco... ...drug approvals and submissions. Candidates should have... ...in Regulatory Affairs CMC within the biotech or pharmaceutical industry... ...and be adept at managing complex global submissions... ...is hybrid, with remote work and occasional...Remote job- Travere Therapeutics is seeking a Manager of Regulatory Affairs to provide regulatory leadership for late-stage development programs. This role includes preparing and executing submissions to Health Authorities and ensuring compliance with regulatory requirements. The...Remote job
- Kite Pharma is looking for a Regulatory Affairs professional to join their San Francisco team. The ideal candidate will have over 7 years of... ...dental, and vision insurance. This role supports a flexible working policy with onsite and remote days. #J-18808-Ljbffr Kite PharmaRemote workFlexible hours
- ...part of the executive leadership team, reporting directly to the CEO, and responsible for crafting the commercial strategy in the biotech sector. The ideal candidate will have a proven track record in executing client strategies and building strong partnerships in the...Remote work
- Travere Therapeutics is looking for a Manager in Regulatory Affairs to lead regulatory strategies for late-stage programs. You'll support cross-... ...functional teams and ensure compliance in preparation and submission processes, particularly for INDs and marketing...Remote job
$116k - $151k
Travere Therapeutics is seeking a Manager, Regulatory Affairs to support regulatory leadership for late-stage development programs. This role... ...to ensure compliance and facilitate successful regulatory submissions. The ideal candidate will possess a Bachelor's degree in...Remote job- Travere Therapeutics is looking for a Manager, Regulatory Affairs to provide regulatory leadership for late-stage development programs. This role... ...with cross-functional teams to achieve regulatory submission success. The ideal candidate will have over 6 years of regulatory...Remote job
- ...Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...Remote job
$116k - $151k
Travere Therapeutics is seeking a Manager, Regulatory Affairs to provide regulatory leadership for late-stage development programs. You will work... ...with project teams to support regulatory planning, submission execution, and interactions with Health Authorities. The...Remote job- A biotech company is seeking a Senior Director of Regulatory Affairs for a fully remote role. This position involves leading regulatory strategy and compliance for early-stage... ...affairs and a strong background in submissions for North American markets. This role offers...Remote job
- Senior Director Regulatory Labeling (Interim) Senior... ...top Regulatory Affairs & C-suite talent with Biotech, CRO, and Pharmaceutical... ...to lead and manage global labeling initiatives... ...development, BLA submission support, and cross-... ...filings. Remote flexibility and collaborative...Remote workPermanent employmentContract workInterim role
$205k - $268k
...Senior Director of Regulatory Operations is... ...owns end-to-end submission planning, execution... ...regulatory information management platform. The... ...in a fast-paced biotech environment, with... ...can be on-site or remote. ~Build, lead,... ...with Regulatory Affairs Leads, Clinical Development...Remote workFull timeFlexible hours- EY in North America is seeking a Senior Manager to lead the Life Sciences Regulatory Submissions practice. You will drive growth, shape regulatory submission strategies... ..., and oversee client engagements across pharma, biotech, and medical device segments, ensuring compliance...
$265.57k - $309.3k
Executive Director, Regulatory Affairs - Amgen Location: Los... ...pioneer the world of biotech in our fight against... ...Responsibilities: Provide management and leadership of... ...documents for regulatory submissions. Contribute to the... ...work models, including remote work arrangements,...Remote workFlexible hours- EmergencyMD seeks a professional for regulatory oversight responsibilities including all US regulatory submissions and acting as the liaison... ...Vice President of Regulatory Affairs. The ideal candidate should... ...The role offers a hybrid or remote work environment with travel...Remote work
- A biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory support, preparing technical documents, and ensuring compliance with FDA regulations...Work at office
$140k - $214k
Vera Therapeutics in Brisbane, California is looking for a Senior Manager, Regulatory CMC to drive regulatory submissions in a collaborative environment. The role involves managing CMC aspects of clinical products and ensuring regulatory compliance. Ideal candidates will...- ...Role Senior Manager/ AD, Regulatory Strategy Location Bay Area (Hybrid) About... ...role in preparing for BLA submission. Key Responsibilities Lead... ...preferred. 10+ years of Regulatory Affairs experience within the... ...skills, and scientific acumen. Remote candidates will also be...Remote work
$100k - $130k
...Professional Placement is seeking a Regulatory Affairs Manager for a medical device manufacturing client... ...regulatory processes and ensuring submissions comply with U.S. and European medical... ...Hospital Regulatory & Accreditation (Remote based in US) Regulatory Compliance Manager...Remote workFull timeMonday to Friday- ...Summary We seek an experienced Regulatory professional to manage regulatory activities... ...reports into the SVP Regulatory Affairs and Quality Assurance. The... ...in the SSF headquarters. Remote US candidates are also... ...manage preparation and submissions (including but not limited...Remote work
$228k - $233k
...a successful company in biotech, and we are committed to... ...Overview: The Director, Global Regulatory Affairs leads Protara’s ex-US... ...will possess ex-US global submissions experience and manage study specific regulatory... ...must be able to work remotely or hybrid in the NYC office...Remote workLocal areaFlexible hours$135k - $150k
...Role Overview The Regulatory Affairs Manager supports the development and... ...reviewing initial health authority submissions, as well as the preparation... ...8+ years of pharmaceutical/biotech R&D experience, including 3... ...This is a remote role; periodic travel to team...Remote work$165.7k - $358.7k
...EY is seeking a dynamic Senior Manager in Life Sciences Regulatory Submissions to lead the practice and drive growth. Located in New York, you will focus on helping clients navigate regulatory compliance in the biotechnology and pharmaceutical sectors. Your key responsibilities...- ...the search for a Senior Director, Regulatory Affairs . This fully remote role (US or Canada) will lead regulatory... ...on early-stage regulatory submissions (INDs, CTAs, pre-INDs). Ensure compliance... ...affairs experience within biotech, pharma, or CRO environments. Advanced...Remote work
$228k - $245k
...biotechnology company in Missouri is seeking a Director of Global Regulatory Affairs responsible for developing and executing regulatory... ...0 years in regulatory affairs and a strong track record of submissions. The position offers a competitive salary of $228,000 to $2...Remote job
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