Manager Global Labelling Regulatory Affairs
4 weeks ago
Global Regulatory Affairs
The Global Regulatory Affairs (GRA) at Biocon consists pool of talented individuals who are the interface between the company and the regulatory agencies across the globe. Within the company, GRA group plays vital role in carving robust regulatory strategy built on strong scientific, technical and regulatory framework. The GRA group embraces individuals with hands on experience on process and product development; analytical sciences; quality management systems; regulatory writing and procedures, leading to successful global submissions and approvals.
Understanding the guidelines, regulations and regulatory processes of each country is challenging especially for complex molecules with dynamic and evolving regulatory landscape. Drug regulatory agencies from the USA (US-FDA), European Union (EMA), Australia (TGA), Canada (Health Canada), Japan (PMDA); and countries from Middle East (S. Arabia, Jordan, Turkey); Pan-American (Brazil, Mexico, Argentina), South Asian (S. Korea, Taiwan, Malaysia), Russian Federation (Russia, Ukraine), African (S. Africa, Algeria) regions have unique country specific submission/review procedures for approval of drugs including biologics/biosimilars.
Robust regulatory competency coupled with focused team effort resulted in us being the “first to file and approval” of a biosimilar Trastuzumab with the US FDA followed by its approval EMA, TGA and Health Canada. Our biosimilar applications for biosimilar peg-filgrastim, insulin glargine, insulin aspart and bevacizumab are also approved/under review across globe including US FDA, EMA, TGA, MedSafe, PMDA and Health Canada. Currently, GRA team at Biocon is working on rich pipeline of biosimilars comprising both partnered and in-house projects spanning therapeutic areas of oncology, immunology, metabolic disorders and general medicines.
Key Responsibilities:
Responsible for 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 projects
Escalate, 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 domain
Preferred 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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