Pharmaceutical Associate Director, Regulatory Affairs

Found in: Jooble US O C2 - 3 weeks ago

Boston MA, United States Scismic Full time

Scismic is supporting the growth of a Boston-based biotechnology company that is discovering and developing novel medicines for cancer.
We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first in role and will report directly to the Head of Development Operations. This individual will provide tactical advice and input into strategy to development teams to achieve efficient and timely development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. You will provide regulatory expertise for product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance
Work collaboratively with CRO and niche providers to support global regulatory filings
Monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs
Together with the development management team, support competitive and effective global regulatory strategies including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
Attend project team meetings to support team with regulatory advice, filing and maintenance requirements for oncology pipeline
Ensure that activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality
Manage regulatory filings and contributor to regulatory and/or development strategy
Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements
Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
Bachelor's degree in Biological Sciences, Pharmacy or related field is required; Advanced degree or certificate in regulatory affairs is preferred
Minimum of 6 years of direct regulatory experience in pharmaceutical or biotechnology industry is required
Solid working knowledge of the drug development process and regulatory requirements in the US is required with global experience preferred
Excellent time management skills and ability to work effectively in a fast-paced environment where timelines and protocols must be met
Proficiency and familiarity with databases or other information management regulatory tools
Excellent organizational and project management skills to frequently coordinate complex activities, often with competing priorities
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
#

  • Associate Director/Director, Regulatory Affairs

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Scismic Full time

    Scismic is supporting the growth of a Boston-based biotechnology company that is discovering and developing novel medicines for cancer. We are seeking an Associate Director/Director of Regulatory Affairs to join the company. This candidate will be first in role and will report directly to the Head of Development Operations. This individual will provide...

  • Regulatory Affairs Director

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Hiring Now! Full time

    About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...

  • Director/Assoc Director Regulatory Affairs

    Found in: Talent US C2 - 2 weeks ago

    Boston, United States Apex Systems Full time

    Job#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location:  Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...

  • Regulatory Affairs Director

    2 weeks ago

    Boston, United States Disability Solutions Full time

    About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI’s unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy,...

  • Regulatory Affairs Director

    19 hours ago

    Boston, United States The Judge Group Full time

    About the Job The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMIs unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...

  • Regulatory Affairs Director

    Found in: beBee jobs US - 2 days ago

    Boston, Massachusetts, United States Foundation Medicine Full time

    About the JobThe Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...

  • Senior Director, Regulatory Affairs

    Found in: beBee jobs US - 4 days ago

    Boston, Massachusetts, United States Proclinical Full time

    Senior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...

  • Regulatory CMC Director or Associate Director

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Dennis Partners Full time

    They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC, you will work closely with cross-functional teams, CMOs, and Health Authorities. This company...

  • Senior Director, Regulatory Affairs

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Hillevax Full time

    HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million...

  • Regulatory Affairs Associate

    2 weeks ago

    Boston, United States WHITE COLLAR TECHNOLOGIES INC Full time

    Job DescriptionJob DescriptionJob DescriptionWe have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting services.We are seeking entry-level experienced personnel or fresh graduate students willing...

  • Director, Regulatory Affairs CMC

    Found in: Jooble US O C2 - 7 days ago

    Boston, MA, United States Stemsourcing Full time

    Define and lead the execution of the global regulatory-CMC strategy from early- to late-phase development and NDA/MAA preparations. Provide strategic and operational support for small molecule pipeline. Represent regulatory-CMC on cross-functional project and technical teams. Develop regulatory-CMC strategies based on regulatory and technical experience,...

  • Director, Regulatory Strategist

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States OSI Full time

    Director, Regulatory Strategist – Global Regulatory Lead (Hybrid) Reporting into the VP Head of Regulatory, you will be responsible for the global regulatory strategic development for one of our lead assets, providing a unique opportunity for a motivated and team-orientated individual who flourishes in an environment where they can help lead and shape...

  • Senior Director, Regulatory Affairs

    2 weeks ago

    Boston, United States HilleVax, Inc. Full time

    HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...

  • Director, Regulatory Affairs

    2 days ago

    Boston, United States Imbria Pharmaceuticals Full time

    Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

  • Director, Regulatory Affairs

    Found in: Appcast Linkedin GBL C2 - 14 hours ago

    Boston, United States Imbria Pharmaceuticals Full time

    Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

  • Regulatory Affairs Manager

    Found in: Jooble US O C2 - 7 days ago

    Boston, MA, United States Dennis Partners Full time

    Our client is developing precision delivery platforms for the treatment of neurological and oncological disorders. They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Reporting into the Senior Director of Regulatory and Clinical Operations, you will be...

  • Senior Director, Regulatory Affairs

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States Alkermes Full time

    The Opportunity We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a...

  • Associate Director Medical Affairs

    Found in: Appcast Linkedin GBL C2 - 14 hours ago

    Boston, United States Advanced Clinical Full time

    Associate Medical Director in Medical AffairsHybrid - on site part-timeBoston, MAPERM - FulltimePharmD or PhD preferred** Motivated and ready to take on the Strategy of Medical Affairs team**Responsibilities and Duties• Work in close collaboration with Field Medical, Global Medical Affairs, Commercial, Customer Engagement, and other cross-functional...

  • Medical Affairs Director

    Found in: Jooble US O C2 - 6 days ago

    Boston, MA, United States Ironwood Pharmaceuticals, Inc. Full time

    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...

  • Medical Affairs Director

    Found in: Jooble US O C2 - 7 days ago

    Boston, MA, United States Ironwood Pharmaceuticals Full time

    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...