Work as Regulatory Affairs Senior Manager at Bristol Myers Squibb

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Post : Senior Manager, Regulatory Affairs

Job Description
Position Summary
Managing the regulatory aspects of projects and products for pre-approval and post approval submissions for biological, new drugs and global and local clinical trials. In addition, participating in project team meetings, by providing regulatory support to ensure compliance with all local requirements.

Roles and Responsibilities
• To manage and execute coordination, compilation and review all marketing and import registration applications and Clinical Trial applications including maintenance applications.
• Responsible for complying the regulatory processes in line with business/R&D objectives to ensure timely registration of new drugs/biologics, new/additional dosage strengths/forms, manufacturing site, support import license, renewal registrations, withdrawals, etc. for commercialized products
• Participate in site to market meetings to support commercial launch.
• Execute day to day regulatory operational task.
• Regulatory collaboration with Medical and Marketing to deliver on regulatory commitments.
• Drives regulatory collaboration with Medical, Business, Supply Chain, QA teams in order to deliver on regulatory commitments.
• Execute local, regional and global initiatives in order to deliver on regulatory commitments.
• Collaboration with regulatory affiliates/local partners in markets within the responsibility in order to deliver on commitments
• Engagement with the regulatory partners in markets within the responsibility, through periodic meetings to achieve BMS business objectives.
• Drives regulatory collaboration with Supply groups and artwork teams in order to ensure uninterrupted access of drugs to patients.
• Executes all regulatory activities including labelling in the region to achieve regulatory compliance.
• Liaises with the global team and the local partners to compile submission ready dossiers (paper and electronic) as per the local regulation to achieve timely HA submissions/approvals in markets within the responsibility.
• Drives implementation of standardized good regulatory practices in the region, ensuring regulatory SOPs are in place and appropriate trainings are taken as necessary.
• Update regulatory archives (VERITY), share points.
• Participate in audits as required.
• Responsible for assuring that approved labelling (PIL, PI, pack) is implemented in production in accordance with local legislation.
• Drives and support local projects and department related assignments.
• Responsible to keep up to date with the regulatory environment within the industry.
• Develop and interact with health authorities and industry bodies from BMS product perspective.
• Involved in Budget preparation.
• 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.
• Provide regulatory and product compliance expertise in the area of promotional inputs, ARRM and label claims for existing and new products.
• Ownership of creating India specific packs, with no disruption in excess of medicines to patients.
• Core member representing regulatory in the IO and Hematology discussions, sharing regulatory strategies and updates.
• Accountable to share regulatory inputs in site to market meeting with the supply chain to facilitate smooth commercial launches.
• Manage the regulatory affairs personnel to keep close track of evolving regulations, ongoing regulatory activities

Candidate Profile
• Required degrees, certifications, and/or licensure relevant to role- Bachelor’s degree or master degree in Science equivalent or BPharm or MPharm
• Professional experience with 5-10 years of relevant regulatory experience

Additional Information
Experience : 5-10 years
Qualification : BPharm or MPharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th July 2024