BD (Becton, Dickinson and Company) Associate Director Global Regulatory Operations Labeling in Franklin Lakes, New Jersey
Job Description SummaryIn this newly created position reporting to the VP of Regulatory Operations, the Associate Director of Global Labeling will play a lead role in building and refining BD's global labeling processes and capabilities, and provide strategic guidance in the development and maintenance of the regulatory content of global labeling, instructions for use (IFUs and eIFUs) etc., including leading cross-functional labeling team workstream for BD's EU Medical Device Regulations (MDR)/In-Vitro Diagnostics Regulations (IVDR) program.
Lead BD's Regulatory labeling function in Regulatory Affairs, and build new, scalable capability and processes to support BD's growth as a commercial organization.
In collaboration with Global Business Unit Regulatory Leads, create, revise and maintain product labeling for BD’s products.
Lead and/or provide support in authoring labeling for each region that aligns with company core labeling requirements for health authorities,
Provide strategic guidance to Core Labeling Teams regarding current and new labeling regulations, competitor labeling, and labeling trends.
Keep up-to-date on emerging clinical and other data, product safety, changes in manufacturing, and completion of post-marketing commitments and requirements that may trigger changes to the global/regional labeling.
Collaborate with Global Regulatory Leads and R&D line the development of labeling strategies and target labeling, IFUs, etc., for new products as well as geo-expansion of products.
Lead and/or assist with the preparation of responses to labeling related queries from health authorities.
Coordinate labeling activities with external alliance partners as required.
Establish processes that ensure accurate records of the data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in labeling in the US, are captured.
Coordinate with stakeholders (such as R&D, Supply Chain, Quality, Operations) regarding timing of labeling supplements, and communicate deadlines for implementation of the labeling changes.
Monitor regulatory environment for new or revised legislation, regulations and guidance documents for health authorities related to product labeling, and assess and communicate impact to BD.
Partner with Regulatory Affairs business Unit Leaders and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
Represent Global Labeling on product-specific Global Regulatory teams and other cross-functional product, development, and safety teams as appropriate.
May support review of advertising and promotional review for BD’s products, as needed.
Maintain any necessary electronic databases for product labeling.
Develop or revise procedures as needed
Maintains awareness of competitive activities. Monitors US and global regulatory environment by reviewing regulatory guidelines, untitled and warning letters to companies published by FDA, and by attendance of appropriate DIA and other industry/FDA meetings.
Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures where appropriate.
Assist with additional regulatory projects as needed. Serves as part of the corporate Regulatory Operations team that drives the strategy for centralization of key functional support.
Able to assess processes to recommend and drive to efficient future state processes including gaining buy in for key stakeholders
Assess and provide recommendations of best practices between business units and drive to standardization of processes where possible.
Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
Excellent analytical and problem solving skills
Sound working knowledge of the Global regulatory environment
Strong coaching and mentoring skills
Ability to effectively communicate complex issues and programs to all levels of the organization.
Experience and knowledge of PC/database skills
Experience and knowledge of document management systems
Leadership:Proven ability to earn the trust of leaders within the organization, including senior leadersProven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectivesProven ability to resolve conflict (striving for win-win outcomes)Proven ability to deliver tough messages in a professional mannerProven ability to act independently and to execute with limited information and ambiguity
Education and/or Experience:
Bachelor degree in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Ability to work in a team environment
Working knowledge of Medical Device and IVD development and approval process and life cycle maintenance
Excellent communication skills; both oral and written
Prior experience in developing and maintaining medical device and IVD product labeling, managing or coordinating core labeling activities for first-time commercialization or product launch.
Minimum of 10 years of professional experience of relevant medical device with 5+ years of relevant regulatory affairs labeling experience. Broad knowledge of the med tech industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.
Primary Work LocationUSA NJ - Franklin Lakes
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