Job Description
responsibilities
Include : -
• To manage and execute coordination, compilation 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.
• Creates and updates local procedural documents. Involved in Budget preparation
• Collaborate with key partners with the country Business function, medical function, Clinical Operations function, Market Access function and Logistics function.
• Can deputize the GRS lead in external and internal shareholder engagement as required
• Support the GRS lead in mentoring and continuous development of the team
Degree Requirements :
Required degrees, certifications, and / or licensure relevant to role- Bachelor’s degree or master’s degree in science equivalent or B Pharm or M Pharm
Experience Requirements :
Professional experience with 5-10 years of relevant regulatory experience
Key Competency Requirements :
Required Knowledge : Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.
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.
Travelling :
Nature and frequency, if required
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-1+ and keep up to date with Covid-1+ boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations
Include : -
• To manage and execute coordination, compilation 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.
• Creates and updates local procedural documents. Involved in Budget preparation
• Collaborate with key partners with the country Business function, medical function, Clinical Operations function, Market Access function and Logistics function.
• Can deputize the GRS lead in external and internal shareholder engagement as required
• Support the GRS lead in mentoring and continuous development of the team
Degree Requirements :
Required degrees, certifications, and / or licensure relevant to role- Bachelor’s degree or master’s degree in science equivalent or B Pharm or M Pharm
Experience Requirements :
Professional experience with 5-10 years of relevant regulatory experience
Key Competency Requirements :
Required Knowledge : Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.
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.
Travelling :
Nature and frequency, if required
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-1+ and keep up to date with Covid-1+ boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations
💡 Quick Summary
Seeking a career-building opportunity? The Manager| RA position is now open for candidates interested in the MIS Executive sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in MIS Executive is a plus.