Sr Director Regulatory Affairs
Proclinical is currently recruiting for a Senior Director of Regulatory Affairs with a leading biopharmaceutical company located in Durham, NC. As the Senior Director, you will be responsible for providing regulatory leadership in support of the development programs at the company.
- Develop and implement regulatory product strategies
- Represent the regulatory function on cross-functional development teams
- Provide regulatory guidance and strategy including identifying and assessing regulatory opportunities, risks, mitigations, and contingencies
- Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, NDA, MAA) throughout the lifecycle of assigned projects
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
- Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
- Ensure that regulatory documents are accurate, complete, and verifiable and confirm compliance with regulatory requirements
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Provide interpretation of and advice regarding regulations, directives, and guidance
- Coordinate and prepare responses to requests for information from regulatory authorities
- Train, manage, and mentor other regulatory affairs personnel
- Work externally to engage in regulatory policy initiatives
- Other duties as assigned
Skills and Requirements:
- Bachelor's degree in a scientific discipline; or advance degree highly desired
- Relevant experience within oncology therapeutics required
- 12+ years regulatory industry experience in biopharmaceuticals
- Knowledge and understanding of global regulations and guidelines
- Previous experience in the preparation and submission of regulatory documents
- Previous experience in attending and leading a team to prepare and conduct health authority meetings (e.g. FDA pre-IND, pre-NDA/BLA, EOP2 meetings, scientific advice, etc.)
- Experience with investigational drugs, including late stage development and marketing application submissions
- Ability to work in a cross-functional team environment with experience managing people and project teams
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.