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Job highlights

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Location: Mumbai, India
Industry: Pharma/Healthcare/Clinical Research
Functional Area: Regulatory Affairs
Application End Date: 30th July 2024

Roles and Responsibilities

  • Regulatory Submissions: Coordinate, compile, and review all marketing, import registration, and clinical trial applications, including maintenance applications.
  • Compliance: Ensure timely registration of new drugs/biologics, new/additional dosage strengths/forms, manufacturing sites, import licenses, renewal registrations, and withdrawals.
  • Support Commercial Launch: Participate in site-to-market meetings.
  • Operational Tasks: Execute day-to-day regulatory operational tasks.
  • Collaboration: Work with Medical, Marketing, Supply Chain, QA, and regulatory affiliates/local partners to deliver on regulatory commitments.
  • Global Initiatives: Execute local, regional, and global initiatives.
  • Regulatory Submissions: Compile submission-ready dossiers (paper and electronic) as per local regulations.
  • Good Regulatory Practices: Implement standardized practices, ensure SOPs are in place, and conduct necessary training.
  • Regulatory Archives: Update regulatory archives and participate in audits.
  • Labelling Compliance: Ensure approved labelling is implemented in production.
  • Project Management: Support local projects and department-related assignments.
  • Regulatory Environment: Stay up-to-date with regulatory changes and industry standards.
  • Health Authorities Interaction: Develop relationships with health authorities and industry bodies.
  • Budget Preparation: Involved in budget preparation.
  • Team Development: Mentor and support continuous development of the team.
  • Product Compliance Expertise: Provide expertise in promotional inputs, ARRM, and label claims.
  • India-specific Packs: Create India-specific packs to ensure no disruption in the supply of medicines.
  • Regulatory Strategy: Represent regulatory in IO and Hematology discussions.
  • Site-to-Market Meetings: Share regulatory inputs to facilitate smooth commercial launches.
  • Evolving Regulations: Manage the regulatory affairs personnel to keep track of evolving regulations and ongoing activities.

Candidate Profile

  • Education: Bachelor’s degree or Master’s degree in Science or equivalent, BPharm or MPharm.
  • Experience: 5-10 years of relevant regulatory experience.

Benefits

Bristol Myers Squibb offers a variety of competitive benefits, services, and programs to help employees achieve their goals both at work and in their personal lives. The BMS Hyderabad integrated global hub focuses on innovative solutions to help patients prevail over serious diseases.

Application Process

End Date: 30th July 2024

For more information and to apply, visit the official job posting on Bristol Myers Squibb’s career page or other job portals.


This role offers an excellent opportunity to contribute to the regulatory compliance and success of Bristol Myers Squibb’s products and initiatives. If you have the required qualifications and experience, consider applying for this impactful position.

Application Link

Bristol Myers Squibb Hiring Senior Manager, Regulatory Affairs

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