Strategic Regulatory Affairs Professional

4 days ago


Dadra and Nagar Haveli, India SUN PHARMA Full time

About the Job:


We are seeking a highly skilled and experienced Senior Executive for our Plant Regulatory Affairs team in Dadra. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements and facilitating business continuity of products.



Key Responsibilities:



  • Maintain up-to-date knowledge of regulatory requirements and guidelines, ensuring effective implementation across the plant.
  • Lead the preparation and submission of documentation for new product filing, re-registration/renewals, and variations.
  • Collaborate with internal stakeholders, including Production, Quality, MSTG, NPQC, CRA, FDD, ADD, and PDD, to ensure seamless regulatory processes.
  • Develop and implement strategies to mitigate risks and resolve queries from regulatory agencies.
  • Provide expert guidance on product life cycle management, variation management, and regulatory inspection support.


Requirements:



  • 7-8 years of experience in regulatory affairs, with a strong background in pharmaceuticals.
  • Bachelor's degree in Pharmacy or a related field, with a Master's degree preferred.
  • Excellent leadership, communication, and teamwork skills.


What We Offer:



  • A competitive salary of ₹14 lakhs per annum, based on industry standards and location.
  • Ongoing professional development opportunities to enhance your skills and expertise.
  • A collaborative work environment that values innovation and growth.


Why Join Us:


Sun Pharma is a leading pharmaceutical company dedicated to improving patient outcomes through innovative medicines and exceptional service. As a Senior Executive, you will be part of a dynamic team committed to delivering high-quality results while fostering a culture of excellence and integrity.



How to Apply:


Please submit your application, along with your resume and cover letter, to us by following the standard recruitment process.



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