Home Regulatory Affairs Manager/Sr Manager Regulatory Affairs | Biosimilars | Sun Pharmaceutical | Vadodara

Manager/Sr Manager Regulatory Affairs | Biosimilars | Sun Pharmaceutical | Vadodara

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Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by over 40 manufacturing facilities spread across six continents and R&D centers across the globe. Innovation is at the core of the Sun.

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¬†We have nearly 2000 scientists working in six research centers across India, Israel, and the USA who have a passion for innovation and longing to provide better healthcare to humanity at large. Our multi-cultural workforce, comprising over 30,000 employees from 50 nationalities, is our biggest strength. We recognize our employee’s passion for growth and empower them to achieve their aspirations. We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable, and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.

Position: Manager/Sr Manager, Regulatory Affairs – Biosimilars

Location: Vadodara, Gujarat, India

Job Description:

  • Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in the pre-approval space.
  • The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
  • Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
  • Provide regulatory leadership as needed in product in-license/due diligence review, product divestment, and product withdrawal.
  • Manage execution of CMC documentation including IND/CTA, original BLA/MAA, agency background packages, and responses to health authority questions per established business processes and systems.

  • Support new technology development within our Company.
  • Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Biologics products worldwide.
  • Conduct all activities with an unwavering focus on compliance
  • Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
  • Demonstrated superior oral and written communication skills in multicultural settings and the ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
  • At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biological CMC development; manufacturing, testing, or licensure in regulated markets for biological products; biosimilars, or related fields.
  • The candidate must be proficient in English; additional language skills are a plus.
  • Experience in Biologics preferred

Qualification: B.Pharma, M.S/M.Sc

Experience: 13-15 Years

Salary: Negotibale

Contact Details:

hrd@sunpharma.com, vignesh.iyer@sunpharma.com

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