Bristol Myers Squibb Hiring Manager – Regulatory Affairs
The role is focused on supporting the execution of BMS plans in India by effectively coordinating with the cross-functional partners. To ensure all aspects with respect to regulatory submission/applications are in compliance to BMS corporate and local regulatory requirements. The role also involves managing all aspects of the new drug application, clinical trial applications, renewal of licenses, and approval process including maintenance activities for ongoing new drugs and Clinical trials.
Execute local country submissions for new registrations, clinical trials, product renewals, and variations.
- Coordinate, compile and review all marketing and import registration applications and Clinical Trial application and maintenance application.
- Responsible for complying the regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of BMS products.
- Ensure the local labeling requirement are developed in alignment with local regulatory requirement and BMS standards
- Responsible for assuring that approved labelling (PIL, PI, pack) is implemented in production in accordance with local legislation.
- Responsible for filing clinical trial applications to the competent regulatory authorities in country, and all following interactions, in line with BMS company policies and practices where applicable.
- Responsible for interactions with Country Regulatory Authorities and feedback to BMS regarding product registrations.
- Drives and support local projects and department related assignments.
- Responsible for identification of opportunities to improve departmental functions/processes.
- Responsible to keep up to date with the regulatory environment within the industry.
- Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.
- Work closely with key partners, global regulatory team and country business function, medical function, Clinical Operations function, Market Access function and Logistics function.
- Creates and updates local procedural documents.
- Required degrees, certifications, and/or licensure relevant to role- Bachelor’s degree or Master’s degree in science or equivalent or BPharm or MPharm
- Professional experience with 5-10 years of relevant regulatory experience
- Required Knowledge: Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work for India registration
- Required Skills: Excellent communication skill & fluency in English, good presentation skills, excellent strategic thinking ability, good negotiation skills, excellent leadership skills, excellent problem-solving ability, excellent coaching skills, and good facilitation skills.