BD (Becton, Dickinson and Company) Vice President, Regulatory Affairs, Medical Segment & Diabetes Care Leader in Franklin Lakes, New Jersey
Job Description SummaryThe VP of Regulatory Affairs (RA), Diabetes Care and Medical Segment Lead is responsible for developing and executing global regulatory strategies designed to obtain regulatory approvals to support the business plan. With minimal supervision, the incumbent will lead the Diabetes Care Regulatory Affairs department assuring products, services and communications meet global regulatory requirements and meet the needs of the business. In addition, this role will oversee RA for two other business units; Medication Delivery Solutions (MDS) and Pharmaceutical Systems (PS). This VP of RA will serve as the chief contact and spokesperson for the Diabetes Care Business unit communication with global regulatory agencies on R&D and business unit matters and ensure that company policies, procedures and practices are in compliance with appropriate FDA and global regulatory requirements.
The incumbent will provide sound regulatory guidance and oversight to other groups within the business unit including but not limited to research, product development and manufacturing organizations. They will provide guidance on regulatory issues related to advertising, labeling, public disclosures, Corporate communications and other public relations activities relating to the business unit. The incumbent will assure consistency of approach and optimal utilization and development of talent for the PS and MDS Business Units regulatory affairs departments. Additionally, this VP of RA will be responsible for leading any Medical Segment regulatory due diligence activities to support potential mergers and acquisitions. This segment leadership role has responsibility for approximately $6.8B in annual revenue for the combined business units.
This position reports directly to the EVP, Regulatory Affairs and Chief Regulatory Officer and is a member of the RA Senior Leadership Team (RA SLT). The role has a dotted line to the President of the Diabetes Care Business Unit. This role will spend approx. 70% of their time as the business unit RA VP and 30% of their time as the Medical Segment RA Lead, directly overseeing a VP and a Sr. Director-level leadership for the MDS and Pharmaceutical Systems BU’s as well as direct management of the DC RA staff.
This VP of RA will utilize their endocrinology device and/or drug regulatory expertise to successfully bring to market new, innovative technologies to continually advance BD’s pen needles, insulin pumps, insulin syringes and other products. This role will require a senior regulatory leader with success in bringing to market diabetes products; both in the US and globally.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA CA - San Diego Bldg A&B
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status