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Team Leader- Ra Labelling Job in Bvr People Consulting

Team Leader- Ra Labelling

Bvr People Consulting 4+ weeks ago
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Job Summary

Job Description

Roles and Responsibilities

Job Title: Team Leader- RA Labelling
Company: Leading Pharma Company in Bangalore Location
Designation: Assistant Manager

No. of Positions: 1

Division: R&D

Department: Regulatory Affairs
Job Location:Bangalore Location
Qualification: M.Pharma / MSc

Years of Experience: 8 to 10 Years
Salary Range: 10 to 12 LPA


Contact person: Mr.Zabi Moghal
Mobile: 7676936384
Email: zabi@bvrpc.com


Job Summary


Manages and leads a team. Communicates company goals, safety practices, and deadlines to team. Motivates team members and assesses performance. Communicates concerns and policies among team members. Perform for all the labelling update and maintenance activities with respect to New Product Development Label creation and Product Life Cycle maintenance update for products in US and Canada Market. Interact with Point of contact for product allocated to understand any data related queries or data availability issues. Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the artwork. Interact on a peer level with colleagues and Canada affiliates for addressing Health Authorities requirement or queries. Maintain all the tracker s for label to ensure the timely submission of the labels to health authority.


Job Responsibility:

  • Responsible for coordination & preparation of regulatory submissions and strategies.
  • Develop & maintain regulatory knowledge of Canada/US regulations.
  • Managing a team that consists of several regulatory affairs associates.
  • Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities to obtain timely product approvals.
  • Provide the teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
  • Works as a member of a team to achieve all outcomes.
  • Performs all work in support of our Corporate Values of Courage, Collaboration, Perseverance and Passion demonstrates strong and visible support of our values.
  • Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada market.
  • Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.
  • Prepare and submit all the supporting documents for labelling submissions as per the type of submission for US and Canada Market.
  • Co-ordinate with POC/ Vendor for Artwork creation and update.
  • Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, etc.)
  • Perform ESG submissions and maintain the acknowledgments.
  • Author the responses and be a decision maker for the changes applicability in the labels
  • Define the priority of the labeling requirements and plan the submission based on priority.
  • Provide input and feedback to departmental process improvement strategy discussions
  • Liaises regularly and develops strong working relationship with external partners and international company affiliates and demonstrates corporate values in the performance of work and in all interactions with others.
  • Maintains user-level knowledge of labelling software s
  • Interacts with other internal departments when necessary.
  • Shows initiative to remain current on new labelling regulations and international guidelines and seeks guidance from Leader and management to enhance knowledge.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements.
  • All other duties as assigned.






    • Salary: Not Disclosed by Recruiter
    Industry: / /
    Functional Area: , , , ,
    Role Category: Drug Regulatory Affairs/Documentation
    Role: Drug Regulatory Director
    Employment Type: Full Time, Permanent
    Experience Required :

    8 to 10 Years

    Vacancy :

    2 - 4 Hires

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