Associate Director/Director, Regulatory Affairs

1 month 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. This role will lead US submission work.

Your role:

  • 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
  • Additional duties and responsibilities as required

What You Bring:

  • 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
  • Early drug submission experience is required
  • Oncology experience 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
  • Well-developed analytical skills and the ability to pay particular attention to details
  • Well-developed written and oral communication and interpersonal skills to frequently collaborate with other team members

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.

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