BD (Becton, Dickinson and Company) Regulatory Affairs Senior Manager - Africa in Johannesburg, South Africa
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.
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
As Regulatory Affairs Senior Manager , you will be valuable partner in the leadership team ensuring that all regulatory aspects and functions support the sustainability of BD in the region.
Other Key Responsibilities:-
Building, managing & developing an effective RA team
Implementing regulatory strategies to secure and maintain the marketing and sales of BD products and support BD Africa strategy
Develop and follow up on regulatory budget
Africa RA activities Planning and prioritization with relevant regulatory affairs partners and local business units/division partners
Implementing and maintaining the RA activities related to importation and distribution.
Ensures efficient review of advertising and promotional material and/or publicly disseminated information for compliance with African country specific requirements (does not include product claims)
Implement and maintain an efficient process for products changes impact assessment in Africa and communicates products changes to relevant partners within regulatory function
Building and managing the external partner network within government authorities and business partners
Actively monitor the regulatory environment to ensure continued compliance and ensure efficient communication thereof
Ensure a detailed understanding of regulatory processes for countries
Proactively communicates regulatory environment changes and impact on BD portfolio to internal partners
Provide training for partners on current and new regulatory requirements to ensure company-wide compliance.
Develop and maintain an efficient documentation and communication system, including corporate tools and resources, ensuring that reporting and metrics are supported and accurately captured
Monthly Reporting of RA Africa related activities, ad hoc reporting as needed
South Africa Responsible Person representing BD South Africa, liaison and point of contact with authorities with regards to regulatory enquiries from MOH.
Responsible for the legal reporting of complaints, adverse events and FSCA/FSN notifications to the Regulatory Authority
Manages regulatory projects for EMEA region as needed
B.S. or B.A. degree in a technical field (e.g., pharmacist, engineering, biology, chemistry). Advanced degree preferred.
Minimum three to five years of directly related professional people management experience in Regulatory Affairs for the medical device, biologic, or pharmaceutical fields
Strong record of successful product submission and registrations of medical devices. Excellent technical writing skills to prepare regulatory documentation and connect with Authorities
Demonstrated project management, negotiation, and communication (written and oral) skills.
Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.
Click on apply if this sounds like you!
Why join us?
A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you 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.
Becton, Dickinson and Company is an Equal Opportunity 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, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work Location
ZAF Johannesburg - Woodlands Dr