Senior Manager - Global Regulatory Sciences
At Bristol-Myers Squibb, we are dedicated to transforming patients' lives through innovative medicines and therapies. As a global leader in the pharmaceutical industry, we are seeking a highly qualified and experienced Senior Manager to join our Regulatory Sciences team. This role is crucial in ensuring compliance with global regulations and driving the successful development and approval of our products. If you are passionate about making a positive impact on patient outcomes and possess a strong background in regulatory affairs, we invite you to apply for this exciting opportunity.
- Develop and implement global regulatory strategies for Bristol-Myers Squibb's products.
- Stay updated on current global regulations and ensure compliance with all relevant standards.
- Collaborate with cross-functional teams to drive the successful development and approval of new medicines and therapies.
- Provide regulatory guidance and support to internal stakeholders, including R&D, clinical, and commercial teams.
- Manage and oversee the preparation and submission of regulatory documents, including INDs, NDAs, and BLAs.
- Monitor and manage regulatory submissions and approvals, ensuring timely and accurate completion.
- Serve as the main point of contact for regulatory agencies and lead interactions and negotiations as needed.
- Conduct risk assessments and develop risk mitigation strategies to ensure successful regulatory outcomes.
- Stay updated on industry trends and best practices in regulatory affairs and provide recommendations for process improvements.
- Mentor and provide guidance to junior team members to ensure their professional growth and development.
- Collaborate with internal and external stakeholders to drive continuous improvement and ensure timely and efficient product development and approval.
- Represent Bristol-Myers Squibb in external meetings and conferences related to regulatory affairs.
- Maintain a high level of attention to detail and accuracy in all regulatory activities.
- Communicate effectively with all levels of the organization, including senior leadership, to provide updates and recommendations on regulatory matters.
- Demonstrate a strong commitment to patient safety and ethical conduct in all regulatory affairs activities.
Extensive Knowledge And Experience In Global Regulatory Affairs: The Ideal Candidate Should Have A Thorough Understanding Of Global Regulatory Requirements And Processes, Including Fda, Ema, And Other Major Health Authorities.
Strong Leadership Skills: As A Senior Manager, The Candidate Will Be Responsible For Leading A Team Of Regulatory Professionals, So Strong Leadership Abilities And The Ability To Effectively Manage And Motivate A Team Are Essential.
Excellent Communication And Interpersonal Skills: The Candidate Should Possess Excellent Written And Verbal Communication Skills, As Well As The Ability To Build Relationships And Effectively Collaborate With Cross-Functional Teams And External Stakeholders.
In-Depth Understanding Of Drug Development Processes: The Candidate Should Have A Comprehensive Understanding Of The Drug Development Lifecycle And Experience In Developing And Executing Global Regulatory Strategies For New Drug Products.
Regulatory Compliance Expertise: The Candidate Should Have A Thorough Understanding Of Regulatory Compliance Requirements And Be Able To Ensure That All Regulatory Submissions And Activities Are In Line With Applicable Regulations And Guidelines.
Quality Assurance
Project Management
Leadership
Drug development
Compliance Management
Risk assessment
Cross-Functional Collaboration
Clinical Trials
Regulatory Strategy
Regulatory Intelligence
Pharmaceutical Regulations
Global Submissions
Communication
Conflict Resolution
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Manager - Global Regulatory Sciences in Hyderabad, Telangana, India is between ₹2,000,000 - ₹4,000,000 per year. This can vary depending on the specific company, industry, and level of experience of the individual. Other factors such as bonuses, benefits, and location can also impact the salary range.
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Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.
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