Manager Global Labelling Regulatory Affairs
3 weeks ago
Creating Labeling Strategy
for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.Ensure
Artwork Management for Initial Submission / Commercial Launch
activities in coordination with CFT team.Responsible for
Promotional Material Review
and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information.Responsible to Coordinate with External Vendor to ensure
Translations documents
are prepared / reviewed to support Global Regulatory Submissions.Responsible for
SPL Preparation for Initial Submission / Labelling Response and Drug Listing
for Approved Products as per business/agency timeline.Change management process of
CCDS , Non-CCDS and Annual reportable labelling changes.Analysis of competitor information (e.g., labels, approval packages) for regulatory policy projects and/or labelling projectsEscalate, notify, and resolve any issues that may impact final labelling submission.Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions.Responsible for managing
Global Labelling Impact Assessment (RLD update / Safety Information Update).Manage Labelling Team members and direct them to follow as per business process and ensure first time right quality.Minimum Qualifications and Experience
B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.Relevant - Minimum 10 to 15 years and above of experience in Global Labelling domainPreferred Qualifications/ Skills
Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.Proactive identification of potential label issues/gaps and develop global regulatory label negotiation strategy with contingency planning.Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labelling regulations, etc.Involved in People Management Activity –Hiring, Training and mentoring associates, leave management, appraisals, KRAs.Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.Depending on experience level, mentor newly hired staff or lead a team of junior staff.Flexibility in responding to changing priorities or dealing with unexpected events.Capability to handle multiple priorities and balance work to achieve business goals.
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Bengaluru, Karnataka, India Biocon Full timeBiocon Biologics is at the forefront of the healthcare industry revolution, placing patient needs above all else. Our goal is to positively impact the lives of billions by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. As a diverse global company, our employees are driven by purpose and passion to collaborate...
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Manager Global Labelling Regulatory Affairs
1 month ago
Bengaluru, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
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Manager Global Labelling Regulatory Affairs
3 weeks ago
Bengaluru, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
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Bengaluru, India Biocon Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
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Bengaluru, India Biocon Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
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Bengaluru, Karnataka, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
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