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Staff Regulatory Affairs Specialist
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Our vision for “function or BU” at BD
This role is placed in BD Pharmaceutical Systems – Advanced Drug Delivery Solutions providing regulatory leadership to product platform teams from early development to new product launches in US, EU and ROW.
About this role:
The Staff Regulatory Affairs Specialist will work in BD Medical – Pharmaceutical Systems Business Unit taking on a lead role at the project level in developing and carrying out regulatory strategy and compliance plans to promote and support new drug delivery solutions for pharma combination product development. The incumbent will represent the RA function on designated platform core team implementing regulatory strategies to support cross-functional stand-alone device and combination product development efforts for platform growth and global expansion. The ideal candidate will have medical device and drug-device combination product experience in the US and EU. The role may have 1-2 indirect reports. This position will work on site in Franklin Lakes, NJ.
Key responsibilities will include:
- Works with RA Manager and Platform Leaders to ensure timely execution of regulatory strategies with business objectives and customer results
- Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers’ regulatory submissions
- Partners with and supports Pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination products approvals
- Performs regulatory impact assessment of changes linked to the field of expertise and assigned platform
- Liaises with cross-functional and cross company teams to meet customer needs in driving new global markets
- Develops and maintains knowledge & awareness on assigned fields of expertise: identify applicable regulations and standards, perform regulatory intelligence/watch, educate appropriate contact partners
- Identifies and communicates potential risks and mitigations to partners
- Support to customers for regulatory advice and registration of their products and interact as needed with the U.S. regulatory agencies and EU Notified Bodies
- Reviews and/or approves product marketing claims and communication, Advertising/promotional materials, and labeling
- Conduct trainings on regulatory issues for staff and for business customers (e.g., Platform, R&D, Marketing and Pharma Partners)
- Participates in internal/external trade, professional, and standards development organizations
- Leads multiple projects with minimal direction
To be successful in this role, you require:
- Knowledge in pharmaceutical and medical devices regulation registration requirements and pathways (variations, renewals, supplements), in the US and EU markets. Global experience is a plus.
- Understanding of product development cycle, clinical phases, organizational change and quality management systems
- Knowledge of pre-fillable syringes and injector devices (pen injector, auto-injector, and on-body injector)
- Experience in meeting with, making presentations to, and negotiating with leadership and/or regulators
- Ability to use your time productively and efficiently (structured and self-organized with strong project management skills)
- Ability to resolve problems and to make appropriate regulatory decisions under pressure
- Ability to adapt, multitask and respond quickly in a constantly evolving and often ambiguous environment, Strong teammate.
- Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)
Education and experience required:
- B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.
- Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields
- Proven experience with project management, negotiation, influencing and interpersonal skills.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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, or any other protected status.
Job posted: 2022-09-05