Associate Director/Director, Regulatory Affairs
Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Associate Director/Director, Regulatory Affairs (level based on candidate experience.) This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development. Working with the Vice President, Regulatory Affairs this position will participate in the development and implementation of regulatory strategies for specific drug development programs (pre and post market approval). This individual will also be responsible for generating and/or review of technical areas for IND/BLA preparation, labeling, operations, and/or regulatory intelligence.
The Associate Director/Director will interact with all aspects of Precigen’s quality, CMC, preclinical, and clinical drug development programs, policies, and procedures ensuring compliance is maintained with all regulatory commitments/requirements.
DUTIES AND RESPONSIBILITIES:
- Responsible for management of day to day Regulatory Affairs activities for investigational and commercial products, serving as liaison between company and FDA and other global Regulatory authorities for assigned programs,
- Develop regulatory strategies for assigned programs, in order to support Precigen’s development and marketing objectives. This will be achieved through analysis of guidances and assessment of other drugs, and in collaboration with Precigen’s senior regulatory management.
- Participation in project team and sub team discussions regarding preclinical, clinical and CMC aspects of drug development, providing regulatory guidance, communicating regulatory goals and timelines, and helping to ensure compliance to the requirements from U.S. and foreign regulatory agencies.
- Provide mentorship to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTX for ex-US studies.
- Help to identify and assess regulatory risks, understanding global imperatives including market-related drivers; plans and implements appropriate mitigation strategies.
- Develop effective professional relationships and promotes a positive company image with FDA and global regulatory authorities.
- Coordinate regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility.
- Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence, being accountable for their completeness and accuracy.
- Responsible for preparation of eCTD documentation for variety of regulatory submissions, most importantly IND and BLA submissions to CBER. Specifically assisting with the writing and/or editing of scientific sections of regulatory documentation needed for Module 2 Summary sections.
- Perform/lead critical analyses of data (clinical, preclinical and manufacturing), independently developing interpretations and conclusions.
- Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations.
- Management of the planning, preparation and submission process for IND and licensing applications.
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree preferably in life science or a related field, advanced degree strongly preferred.
- Ten (10) years of progressive experience in biotech or pharmaceutical environment, with demonstrated direct regulatory affairs experience. RAC is desirable but not required.
- Comprehensive knowledge of regional health authority regulations and advanced knowledge of global regulations/guidelines governing development of pharmaceuticals, biologics and medical devices.
- Experience in compilation of Regulatory submissions using eCTD (electronic common technical document) preferred.
- Demonstrated experience with US BLA/NDA submissions, preferably in oncology/hematology.
- Demonstrated leadership and project management skills, including cross-functional communication.
- Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF.
- Excellent verbal and written communication skills.
- Strong organizational and analytical skills with attention to detail.
- Ability to handle multiple competing priorities and work well under pressure.
- Prior experience with management of direct reports.
- Demonstrated interactions with US Regulatory authorities.
DESIRED KEY COMPETENCIES:
- Exceptional leadership, planning, organization, and execution skills.
- Organized self-starter.
- Ability to understand and execute on the company’s mission and values.
- Strong analytical and decision-making skills with attention to detail and quality.
- Exhibits impeccable confidentiality on sensitive, supporting tasks.
- Ability to anticipate and solve problems while analyzing complex issues and environments.
- Ability to communicate and work effectively with all levels of employees in various communication mediums.
- Possess a high degree of personal responsibility.
- Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
- Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention.
- Demonstrates the highest ethical standards and trustworthiness.
- Strong verbal and written communication and interpersonal skills.
Learn more here
Job posted: 2021-03-20