Senior Regulatory Affairs Specialist
On-siteBengaluru, Karnataka, India
Job Summary
Monitor regulatory requirements, guidance documents, and industry standards across applicable global markets. Research and compile regulatory requirements, approval pathways, and compliance information for products and programs. Collect, organize, and maintain regulatory intelligence files, submission documentation, and supporting records. Assist in preparing regulatory dossiers, pre-submission packages, and submission materials for regulatory agencies. Track regulatory submissions and applications under review and provide status updates to stakeholders. Maintain records of communications, commitments, and outcomes with regulatory authorities and other stakeholders. Coordinate meeting logistics and develop supporting materials for discussions with regulatory agencies and internal teams. Organize and support the review of preclinical, clinical, quality, and technical documentation used to meet regulatory requirements.
Required Qualifications
- Bachelor's degree
- 6-10 years of work experience
- Demonstrated ability to work with technical, scientific, or regulated documentation through academic, internship, co-op, or professional experience
- Must be able to work the majority to 100% of time from an alternate workplace
- Must work within the country of the job requisition location
Desired Qualifications
- Master's degree in Regulatory Science or a related field
- Experience supporting regulatory affairs, quality, clinical, research, or compliance activities in a regulated industry
- Familiarity with medical device, pharmaceutical, biotechnology, or other regulated industry regulations and standards
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