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    Regulatory Affairs Associate Director - Boston, MA, United States - Scismic

    Scismic
    Scismic Boston, MA, United States

    3 weeks ago

    Default job background
    Description
    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.

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