Vice President, Regulatory Affairs Oncology Strategy
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Vice President, Regulatory Affairs Oncology Strategy, are to:
- Holds worldwide accountability for developing, aligning, communicating and implementing the regulatory strategies for all active development projects and products under his/her responsibility, to ensure the sustainability and growth of the Pharma business. Provides guidance and oversight to Global Regulatory Strategists (GRS) with regard to the development and implementation of global regulatory strategies to ensure alignment to the oncology portfolio and that key regions are captured in the global regulatory strategy. Develops Regulatory Strategy for directly assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan);
- Proposes innovative approaches to resolve complex regulatory issues and increase speed of novel medicines to patients;
- Sets challenging, but regulatory achievable objectives, calculating in taking risks in the regulatory setting;
- Actively involved in decision making on all key development questions in consideration of the oncology portfolio via an assessment on the probability of regulatory success;
- Advises the business and R&D functions in steering the product portfolio and achieving the Life Cycle Management, Product Stewardship and Product Defense objectives and the time to market / peak sales objectives for projects by working closely with Global Portfolio Management, Regions and Countries;
- Advises Pharma D-RA, OGC, ODC, other R&D functions and business and/or other functional areas of regulatory trends and their relevance to the oncology portfolio. Shape the global regulatory environment to ensure that we positively influence the landscape to meet the Oncology SBU’s business needs;
- Develops the local and global regulatory project goals from development through life cycle. Supervises the development of multiple project goals on a local and global level;
- Supervises regulatory members of the global project team. Represents Global Regulatory Affairs on directly assigned global Project Teams;
- Responsible for training of the GRS and the oversight and review of submissions. Ensure submissions are consistent with the oncology portfolio strategy. For directly assigned projects develops submission materials for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global HA regulations and completeness of submission;
- Supervise and drives preparations for meetings and teleconferences with local and global HA officials;
- Conduct regulatory due diligence on potential in-licensing opportunities;
- Responsible for joint steering committee, if projects are handled with partners;
- Ensures appropriate issue management within the worldwide Pharma organization for respective products.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Advanced technical degree Ph.D., DVM or Pharm D in life sciences preferred 10 years in medical research activities and over 7 years include local/ global regulatory experience in related TA area, or MS degree with 12 years of medical research activities of which Over 7 years include local/global regulatory experience in related TA area,
- Strong leadership skills to develop talent, strong strategic mindset and vision and purpose drive;
- Expert knowledge of the regional and global regulations, demonstrated interactions with local and global health authorities;
- Excellent communication skills, verbal and written, and strong analytical and negotiations skills are required;
- Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills;
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives;
- A clear understanding of cultural and business needs in leading a diverse team.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Location: United States : New Jersey : Whippany
Reference Code: 42432
+ 1 888-473-1001, option #5