HomeRegulatory AffairsManager/Associate Manager | Regulatory Affairs - Labeling | Biocon Ltd | Bengaluru

Manager/Associate Manager | Regulatory Affairs – Labeling | Biocon Ltd | Bengaluru

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Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Sr Executive/Assistant Manager – Regulatory Affairs – US

Location: Bengaluru, Karnataka, India

Job Description:

  • The Regulatory Labeling Manager is a tactical and strategic role within GF Regulatory Affairs and is generally responsible for preparing, reviewing, and submitting high-quality regulatory submissions intended for US-FDA, EU, Canada, Brazil, China, and other ROW countries within company timelines ad in accordance with respective regulatory guidelines and applicable laws.
  • Submissions will include original applications (e.g. ANDAs, MA), amendments, supplements, Annual Reports, Advertising and Promotion materials, and REMS.
  • This position, under the direction of the legal/IP team, prepares appropriate carve-outs based on submission strategies.
  • This individual is responsible for the preparation of labeling in meeting regulatory submission timelines, and also responsible for preparing, reviewing, and submitting Structured Product Labeling to FDA and is responsible for Drug Listing activities.

Essential Duties and Responsibilities:

  • Preparation and review of labeling (PIL/SMPC/Product Monograph/artworks) as per regional regulatory requirements to ensure error-free submission.
  • Comprehensive and up-to-date knowledge on global (US/EU/Canada/China and other countries) regulatory guidelines/requirements for labeling.
  • Keeping a regular track of RLD/Reference product labeling changes for timely submission of amendments/supplements/variations.
  • Working in close coordination with IP to ensure that the content of our proposed labeling is inline with the patent certifications/exclusivity statement and that necessary carveouts have been done.
  • Keeping track of patent/exclusivity expiry to ensure that the carved out information is included back in the labeling.
  • Providing artwork and labeling content to artwork team and review of artworks (carton and container) prepared by artwork team.
  • Handling of labeling deficiencies and post-approval labeling changes.
  • Supporting SCM and launch team in product launch activities after getting approval from regulatory agencies.
  • Thorough knowledge of serialization requirements.
  • Hands-on experience in handling labeling tools (LabelBridge) used to prepare SPL (drug listing, establishment registration, etc.).
  • Coordinating with vendors for preparation and review of multilingual labeling/high-quality translations and respective country-specific artworks for EU including readability testing as per requirements.

Qualification: M.Pharma

Experience: 9-13 Years of Relevant Experience

Salary: Negotiable

Contact Details:

Ms. Rashmi Gupta

careers@biocon.com, human.resources@biocon.com,

rashmi.gupta@biocon.com

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