Senior Regulatory Submissions Lead - Remote
Scorpion Therapeutics
Scorpion Therapeutics is looking for a Senior Specialist in Regulatory Operations to oversee submission management across the development pipeline and support the commercial portfolio. This role requires experience in regulatory operations in the biotech/pharma sectors, including proficiency in eCTD standards and regulatory submissions. The ideal candidate will be responsible for managing submissions, overseeing regulatory documents, and ensuring the compliance and quality of deliverables. The position offers a comprehensive benefits package including medical, dental, vision, 401k, and paid time off. #J-18808-Ljbffr
- Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...incentives, and generous PTO. This position offers a remote work option with travel as needed. #J-18808-Ljbffr Praxis...Remote jobSeniorRegulatory
- ...Associate Director, Medical Writing to oversee regulatory submissions and manage related documentation. This... ...preferred. The Associate Director will lead a team of medical writers, ensuring... ...and project management abilities. Remote work is available, but face-to-face interactions...Remote jobSeniorRegulatory
$70k - $130k
Tonix Pharmaceuticals is seeking a Senior Specialist, Regulatory Operations to manage submission processes across the development pipeline. This role requires 3... ...dental, and retirement options. Flexibility to work remotely is also available. #J-18808-Ljbffr Tonix...Remote jobSeniorRegulatory- BridgeBio Pharma in California is seeking a Regulatory CMC professional to lead the regulatory strategy for IND, NDA, and MAA submissions. The role requires extensive experience in... ...allows for a hybrid work model, combining remote work with periodic office visits in San...Remote jobSeniorRegulatoryWork at office
$130k - $150k
.... The candidate will be responsible for producing high-quality regulatory documents and collaborating with cross-functional teams to ensure... ...offers a salary range of $130,000 - $150,000 USD annually, remote work flexibility, and a comprehensive benefits package. #J-1880...Remote jobSeniorRegulatory- Creative Solutions Services, LLC is seeking a Remote Senior Medical Writer to join their Regulatory Operations team. The role involves preparing clinical regulatory documents and managing multiple projects while ensuring compliance with guidelines. The ideal candidate will...Remote jobSeniorRegulatory
$130k - $150k
...writing experience in a Sponsor or CRO setting, along with a Bachelor’s degree in a scientific discipline. Responsibilities include leading the preparation of clinical trial documents and collaborating with various teams. Competitive salary between $130,000 and $150,000...Remote jobSeniorRegulatoryFlexible hours- Biocartis is searching for a Senior Regulatory Affairs Specialist to develop regulatory strategies... ...with IVDR and global standards. This remote position requires a Bachelor's degree... ...teams, preparing regulatory submissions, and monitoring changing market requirements...Remote jobSeniorRegulatory
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote jobSeniorRegulatory
$100k - $115k
BBVA is looking for a Regulatory Reporting Manager for its New York Branch. This role will involve leading the preparation and submission of U.S. regulatory reports while ensuring accuracy... ...hybrid work model, balancing office and remote work, with a competitive salary...Remote workSeniorRegulatoryWork at office$115k - $185k
A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote jobSeniorRegulatory- A leading staffing firm is seeking a Senior Manager of Biostatistics to provide strategic leadership in clinical development. This remote role requires a PhD in Statistics or Biostatistics with... ...design and contributing to regulatory submissions. The position is for 6+...Remote jobSeniorRegulatory
- A leading biotechnology company is seeking a Regulatory Writing Senior Manager to lead writing activities for product submissions. This role involves authoring and overseeing regulatory documents... ...competitive salary and flexible remote work arrangements. #J-18808-Ljbffr...Remote jobSeniorRegulatoryFlexible hours
- ...healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville,... ...FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s... ...communication skills. This position is remote and requires some travel. Competitive...Remote jobSeniorRegulatory
$110k - $135k
...DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance within... ...sciences and diagnostics. You will lead the creation of regulatory... ...diagnostics. This position is fully remote, offers a salary range of $110,0...Remote jobSeniorRegulatory- Optimapharm is hiring a Regulatory and Startup Specialist to support global clinical trials. This role involves leading regulatory submissions and coordinating study start-up activities. Suitable candidates should possess a degree in life sciences and have at least 4 years...Remote jobSeniorRegulatoryFlexible hours
- INC Research is seeking a Senior Medical Writer to support clinical study and regulatory project teams. This position is home based anywhere in the US. The ideal... ...deliverables like clinical protocols, IND submissions, and more, adhering to regulatory standards. Applicants...Remote jobSeniorRegulatoryWork from home
- ADMA Biologics in Boca Raton, FL is seeking a Senior Manager for Regulatory Affairs to supervise regulatory document submissions to the FDA. The role requires ten years of experience in pharmaceutical development and strong skills in regulatory compliance. This position...SeniorRegulatory
$190k - $260k
Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years of regulatory... .... The successful candidate will manage regulatory submissions and ensure compliance with global regulations while fostering...SeniorRegulatory- 6AM City, LLC in False Pass, Alaska, is seeking a Group Leader to manage and submit regulatory submissions while ensuring compliance with all relevant regulations. Ideal candidates will have a Bachelor’s degree in Pharmacy or a related field, and at least 5 years of experience...SeniorRegulatory
$170k - $200k
...marketed products. Key responsibilities include management of vendor relationships, signal detection, and collaboration on regulatory submissions. The ideal candidate will have a strong background in pharmacovigilance practices and experience in neurology or autoimmune...SeniorRegulatory- Itlearn360 is seeking a Senior Medical Writer in South San Francisco. This role involves overseeing high-quality documents for clinical trials and regulatory submissions. The ideal candidate should have 8-10 years of scientific writing experience, including expertise in...Remote jobSeniorRegulatoryHourly payTemporary work
- Creative Solutions Services, LLC in Cambridge, Massachusetts is seeking a Regulatory Submissions Lead to oversee publishing activities for IND, NDA, ANDA, and more. The ideal candidate will manage submission processes, ensure quality control, and mentor team members. A...SeniorRegulatory
- Katalyst CRO is hiring for a position in Austin, Texas, focused on leading and managing publishing activities for regulatory submissions. The successful candidate will have a Bachelor's or Master's degree in a related field and at least 5 years of experience in the regulatory...SeniorRegulatory
- Oracle in the United Kingdom is seeking a Senior Regulatory Analyst specializing in Non-Interventional Studies. The role focuses on coordinating complex international regulatory submissions that impact healthcare innovations. Candidates should possess a PharmD or Master...SeniorRegulatoryFlexible hours
- Women In Bio seeks a Regulatory Affairs Specialist to lead the planning and delivery of regulatory submission dossiers in the United States. You will collaborate with teams across... ...allows for both in-office teamwork and remote focused work days. #J-18808-Ljbffr Women In...Remote workRegulatoryWork at office
- Katalyst CRO in Edison, NJ is seeking a qualified individual to lead publishing activities for regulatory submissions. The ideal candidate has a Bachelor’s or Master’s degree in Pharmacy or Life Sciences, with 5-10 years of experience in eCTD/NeeS publishing. Responsibilities...SeniorRegulatory
- A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical Science and expertise in regulatory... ...D teams, shape study designs, and prepare submission-ready documentation for FDA submissions....Remote jobSeniorRegulatoryFlexible hours
- GSK is looking for a professional in regulatory affairs to lead the planning and delivery of regulatory submission dossiers. The role involves collaboration with various... ...for both in-office collaboration and focused remote work. Candidates should have at least 3 years...Remote workRegulatoryWork at office
$221k - $286k
Kite Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide global leadership... ...overseeing global CMC strategies, submissions, and managing workforce talent.... ...position offers flexible work with remote options. #J-18808-Ljbffr Kite PharmaRemote workRegulatoryFlexible hours
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