HomeRegulatory AffairsHead - Regulatory Affairs | Strides Pharma Science | Bengaluru

Head – Regulatory Affairs | Strides Pharma Science | Bengaluru

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Stelis Biopharma Pvt. Ltd. (Stelis) was started in 2013 by Strides Pharma Science Limited (Strides) to drive a global affordable biopharma business. Via on-going investment, Strides remains a majority owner of Stelis and it continues to operate as an independent and autonomous subsidiary company.

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Its world-class cGMP manufacturing facilities were commissioned in 2018, positioning the company as a recognized leader in the development of biosimilars & follow-on biologics and in the provision of world-class CDMO services.

Stelis is a fully vertically integrated biopharmaceutical company. Its operations include R&D, process development, scale-up & end-to-end cGMP manufacturing capabilities from microbial drug substance manufacture through Drug Product manufacture in all formats and packaging. Stelis’ state-of-the-art research & development facility and 200,000 sq. ft. fully integrated cGMP manufacturing facility are located in Bangalore, India. Facilities cater to the development and cGMP manufacture of biologics and injectables conforming to international standards including the US FDA and EMA.

Position: Head – Regulatory Affairs – Oral Dosage Forms

Location: Bengaluru, Karnataka, India

Jobs Description:

  • Work with the multidisciplinary project team in meeting established objectives; prioritize projects to meet internal and external filing deadlines; and provide regulatory guidance
  • Leading preparation of regulatory submissions, product registration, and post-approval life cycle management for Regulated (US markets) and Other Regulated Markets (Europe, Australia & Canada).
  • Will provide overall leadership and regulatory direction on projects by working with internal program teams to develop a regulatory strategy and development plans and will interface with external consultants and regulatory agencies in developing regulatory submissions in other regulated markets
  • Assist legal counsel and corporate clients who are primarily pharmaceutical, biotech, medical device, and diagnostics companies, with complex regulatory and compliance issues
  • Provide leadership to resolve critical regulatory issues, bring the appropriate experts together as needed

  • Lead cross-functional efforts to deliver high-quality submissions, ensuring that the Manager is aware of any major issues with the project, including any changes to plan or risks
  • Keep abreast of regulatory guidance and technical/scientific developments relevant to projects
  • Build capability in the Regulatory Affairs department, manage budgets and project timelines, identify and address gaps in planning and resourcing

Desired Candidate Profile:

  • Demonstrated excellence in regulatory liaison/strategy including a broad understanding of international regulations, processes, and issues in drug development
  • Flexibility and responsiveness in managing multiple projects in sometimes high-pressure situations simultaneous
  • Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box
  • Regulatory affairs certification (RAC) a plus
  • Knowledge of both GCP and GMP regulations

Qualification: Masters degree in life sciences, chemistry, pharmaceutics, or a related discipline
Experience: 12 + years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry
Salary: Negotiable

Contact Details:

Mr. Vinod Gopishetty

vinod.gopishetty@strides.com

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