Dova is currently recruiting an Associate Director, Regulatory Affairs to join our team in Durham, NC. In the role, you will be responsible for development and implementation of worldwide regulatory strategy for their assigned projects/products. You will function with a high degree of independence and provide regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manage projects, functioning as the single, accountable, global point of contact on those projects. May interact directly with FDA and other regulatory agencies with regard to assigned projects/products.
- Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
- Lead the development and implementation of sound regulatory objectives, strategies, and plans for assigned projects/products
- Oversee the preparation and submission of regulatory documentation to FDA and other regulatory authorities worldwide. This documentation may include but is not limited to INDs, NDAs/sNDAs, CTAs, MAAs, orphan drug applications, annual reports and amendments.
- Manage the assembly and internal review of these submissions. Assure that all submissions meet the highest regulatory standards for content and format. Coordinate and consult with other departments on the content, review and assembly of regulatory documentation.
- Assist with development and implementation of internal policies and procedures relating to all aspects of the Regulatory Affairs functions.
- Depending on experience of the successful candidate, may serve as primary contact to regulatory agencies and foster positive and effective working relationships between project team members and health authority reviewers.
- Assist in the preparation and conduct of all meetings and interactions with regulatory authorities.
- Present regulatory strategies and issues at internal corporate meetings, demonstrating excellent presentation skills.
- Stay abreast of and appropriately apply new regulatory and compliance requirements and legislation in a timely manner.
- Serve as an expert and reliable regulatory affairs and compliance resource for all units of the company, including business development, manufacturing, research and development, and sales and marketing.
- Promote productive interactions with various external consultants, as necessary.
- Ability to achieve optimal results with limited day-to-day direction from Head of Regulatory Affairs
- 12+ years of experience in the pharmaceutical/biotech or related industry
- 10+ years in Regulatory Affairs
- Diverse experience including drugs, biologics, and international filings would be useful for this position
- Proficiency with document management applications and MS Office.
- Occasional travel to other locations, partner organizations, regulatory agency meetings, or industry meetings may be required
- Bachelor’s degree in a science related field; advanced degree preferred
Why Join Us?
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. At our Durham office, we provide a sleek and high-tech work environment with glass walls and adjustable desks. All employees are issued laptops, have access to a stocked kitchen, and are included in Free Lunch Fridays! We also offer a competitive benefits package, to support the health and happiness of our staff.
An Equal Opportunity Employer
Dova is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Dova are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.