Regulatory Affairs Professional

14 hours ago

Chennai, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878
Regulatory Affairs Specialist

This is a key role within our organization, responsible for ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist will work closely with cross-functional teams to prepare and submit amendments and supplements for assigned products.

Key Responsibilities:
  • Amendment and Supplement Preparation: Prepare, review, and submit amendments and supplements for the assigned products, ensuring timely submission and compliance with regulatory requirements.
  • Regulatory Submission Support: Provide support for regulatory submissions, including preparation of summary documents and responses to Agency queries.
  • Global Annual Report Compilation: Compile and submit Global Annual Reports, ensuring accuracy and completeness of data.
  • Review and Approval Process: Review stability protocols and reports, analytical method validation protocols and reports, raw material, packaging material, finished product specifications, finished product stability specifications, testing procedures, batch records, Process Validation Protocol, hold time study protocols and reports, Product Development Report, and executed documents, including executed BMR, Certificate of Analysis, to ensure compliance with regulatory requirements.
Requirements:
  • Education: Bachelor's degree in a related field, such as life sciences or a technical discipline.
  • Experience: Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Skills: Strong knowledge of regulatory requirements, excellent communication and interpersonal skills, ability to work independently and as part of a team.
Benefits:

This is an exciting opportunity to join our dynamic team and contribute to the success of our organization. As a Regulatory Affairs Specialist, you will have the opportunity to work on a wide range of projects, develop your skills and expertise, and take advantage of opportunities for professional growth and development.

We offer a competitive salary, comprehensive benefits package, and a supportive work environment. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this challenging and rewarding role.

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