about 2 months ago
A publicly held biotechnology company committed to a bold mission: to discover, design, develop and deliver curative therapies that address the underlying drivers of heart disease. Advancing a deep and diverse pipeline that includes both gene therapies and small molecules.
Currently seeking a highly motivated professional to join our team in Regulatory Affairs. The position will require regulatory oversight for regulatory activities across the product lifecycle, from development through post-approval, while overseeing department activities and cross-functional teams. To be successful in this role, you must be able to provide clear direction, communicate clearly (in verbal and written form), and display exemplary organizational skills. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.
Essential Duties & Responsibilities
- Leads the implementation of regulatory strategies that result in the successful clinical trial applications, marketing application, and post-approval commercialization of company's products and product-candidates.
- Serves as the regulatory agency contact (at the FDA and international agencies) by fostering strong relationships and acting as a credible, reputable, and effective advocate for company
- Executes regulatory guidance and support as determined by the management team, both strategically and operationally
- Assist with regulatory project plans and timelines, tracks submission documentation, and ensures all key goals are met on time
- Coordinate the collection of documents, records, reports, and data from multidisciplinary teams for inclusion in regulatory documents
- Responsible for the development and authoring of regulatory documents such as initial IND applications, IND amendments, meeting requests, meeting packages, CTAs, and IMPDs, etc.
- Compile and maintains regulatory databases or systems and maintain regulatory files in a compliant fashion
- Assist in gathering requirements and helps build regulatory guidance and strategy
- Leads regulatory meetings, agendas, meeting minutes and action items
- Develop and manage internal regulatory procedures to ensure compliance and build regulatory infrastructure.
- BS degree, advanced degree preferred in life sciences
- At least 5 years of experience working in a Regulatory Affairs capacity. Proven leadership experience required
- Demonstrated understanding of Regulatory and/or drug development processes for gene and cell therapies preferred, biologics experience as a minimum
- Strong organizational, project and time management skills
- Effective communication skills, both written and verbal
- Sound judgment, problem solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems
- Solutions-oriented with strong problem-solving skills
- Ability to work effectively with cross-functional teams
- Demonstrated experience coordinating interdisciplinary teams and external vendors
- Experience with MS Office programs, prefer experience with Veeva RIM Vault
- Good culture fit with company Core Values