Bristol Myers Squibb Hiring B Pharma & M Pharma Candidates
Bristol Myers Squibb announces job opening for pharma candidates, B Pharma & M Pharma job opening 2022. Pharmacy job opening 2022. Bristol Myers Squibb job vacancy for pharma candidates. B Pharma job, M Pharma job opening 2022. Candidates with bachelor’s and master’s degree in pharma may apply for the job vacancy. Check out all the details on the same below:
Job Title: Manager, Regulatory Affairs India
Location: Mumbai, India
Department: Medical and Regulatory Affairs
Id: R1559270
Eligibility Criteria:
- 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.
Key Responsibilities
- Coordinate, compile, and review all marketing and import registration applications and Clinical Trial applications, and maintenance applications.
- Responsible for complying with 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 requirements and BMS standards
- Responsible for assuring that approved labeling (PIL, PI, pack) is implemented in production in accordance with local legislation.
- Responsible for filing clinical trial applications to the competent regulatory authorities in the 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 supports local projects and department-related assignments.
- Responsible for the identification of opportunities to improve departmental functions/processes.
- Responsible for keeping 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.
Apply Online
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