Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Regulatory Affairs Specialist supporting regulatory activities across multiple projects at BD, ensuring compliance with EU regulations. Collaborating with cross-functional teams on documentation and product lines.
Responsibilities
- Responsible for supporting and executing regulatory activities across multiple projects and UCC and Surgery product lines
- Reviewing and approving advertising and promotional materials to ensure compliance with regulatory legislations
- Maintaining and updating the Technical Documentation Repository
- Addressing product-specific regulatory queries from local teams
- Leading non-product-specific regulatory projects
- Overseeing label review and approval processes
- Collaborating with quality teams to provide regulatory input on First Article Inspection
- Supporting regional initiatives for CE marking and other regulatory asks
- Serving as a subject matter expert on EU regulations
Requirements
- Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master’s degree preferred)
- 3-5 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or life sciences industries
- Experience with EMEA regulatory standards and CE mark requirements is strongly preferred
- Proficiency in managing regulatory documentation, labeling requirements, and documentation repositories
- High level of accuracy in reviewing and approving labeling, advertising, and promotional materials
- Strong collaborative skills and a proactive approach to support functions and business unit-specific projects
- Strong proficiency in English written and spoken.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
- Competitive package of compensation and benefits
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