BD (Becton, Dickinson and Company) Regulatory Affairs Manager in San Jose, California
Job Description Summary
The Regulatory Affairs (RA) Manager is responsible for providing regulatory strategy and regulatory support to the Cell Therapy Enablement and Research Platforms, and representing RA on these platforms’ leadership team. Besides leading the RA group supporting the aforementioned platforms, this individual will have hands-on responsibilities such as representing the RA function on designated core teams, conducting business interactions with customers and regulatory authorities surrounding regulatory pathway, performance claims, and supporting data, approving labeling (including advertising and promotional materials) in the context of submissions or registrations, and serving as the regulatory expert on the projects.
He/she is responsible for assisting VP RA in advocating least burdensome approaches to product clearance/approval, interpreting and providing regulatory requirements. This individual will help ensure department processes and procedures related to regulatory responsibilities are compliant, current and efficient.
The RA manager solves problems of medium to high complexity and diverse scope in an evolving regulatory environment.
Creates and executes RA strategies and plans for products (flow cytometry sorter, reagents, and assays) supporting cell therapies.
Prepares, submits, and maintains regulatory submissions, including but not limited to device master files for products supporting cell therapies, Machinery Directive technical document for RUO instruments including instruments supporting cell therapies, and EU/IVDR/MDR Technical Documentation for products supporting cell therapies. When needed, participate in the preparation of classification requests, pre-submissions, and 510(k) premarket notifications for other products at BDB.
Maintains Master File Desk Procedure, and ensure compliance to and training of the procedure.
Represents Regulatory Affairs in product development core teams, and provides regulatory guidance to product development and manufacturing controls, such as safety, cleanroom requirements for cGMP reagents used for cell therapy manufacturing.
As a core team member of the cell therapy product development teams, represents the business in interactions and negotiations with regulatory agencies regarding regulatory pathways for the novel products, premarket submission requirements, strategies, labeling claims, performance or clinical data, etc. Organizes and manages meetings with regulators, including agendas and training/preparation of business unit personnel attending the meetings.
Reviews and approves labeling, advertising and promotional materials.
Performs impact assessment of product and process changes on regulatory filing.
Monitors FDA, EU and other agency laws and regulations associated with cell therapies and research use only products, and provides their interpretation to regulatory leadership. Provides comments to RA management for inclusion in BDX responses to FDA and other agency legislation/regulation/guidance.
Mentors and develops regulatory associate(s) for career advancement.
Reviews documents for product development and manufacturing processes to assure appropriate data for regulatory submissions and compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale.
Attends and represents BDB in external organization events at a local level and on a national level as assigned.
Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.
Lives and promotes the BD values.
Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics
Performs other duties and assignments as required.
Education and Experience:
Minimum of a M.S. degree in life science field (molecular biology, biology, microbiology, chemistry, etc.).
Ph.D a plus. Certifications (RAC, CQA, CQM, etc.) encouraged.
Minimum of 4 years directly applicable regulatory submissions experience (Master Files, 510(k)s, Tech Files, etc.) in an IVD company or technical experience with cellular therapies. Flow cytometer experience a super plus.
Either well versed in the aspects of regulatory strategy plan creation, design control, RUO/ASR/IVD regulations, master files, technical files, and QSR/ISO 9001/13485 or have strong technical experience (see #2 above) in a regulated environment (companies or clinical labs).
Minimum 2 years of people management experience.
Knowledge and Skills:
Interprets specific regulations related to products supporting cellular therapies and research use only products, and has working knowledge of IVD and/or biologic drug regulations with focus in US and EU.
Demonstrated self-starter, learning agility, and highly motivated.
Demonstrated people leadership with an emphasis on talent development.
Holds understanding of technical/scientific principles that relate to products used to support cell therapies (e.g., flow cytometry, aseptic processing, sterility testing, etc.). Demonstrates excellence in both oral and written communication skills including the ability to communicate cross culture; work with others in team environment; effectively interact with technical personnel (e.g., scientists, engineers, etc.); and negotiate with regulators.
Demonstrates ability to be effective in complex projects with ambiguity and/or rapid change. Multiplexes well to handle multiple tasks and to prioritize and schedule work to meet business needs.
Demonstrates organizational and planning skills, including action oriented, focused urgency and driving for results Shows proficiency in team skills with ability to influence others.
Asserts own ideas and persuades others. Fosters collaboration among team members.
Computer literacy (SAP, PC, Microsoft Word/Excel/Powerpoint)
Primary Work LocationUSA CA - San Jose
Work ShiftNA (United States of America)
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