Regulatory Affairs Specialist

1 week ago

Thoothukudi, Tamil Nadu, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Regulatory Affairs Specialist

Job Description:

We are seeking a highly skilled and detail-oriented Regulatory Affairs Specialist to support end-to-end submissions for global markets. This role will involve working closely with cross-functional teams to ensure compliance with global regulatory requirements.

The successful candidate will have experience in managing Initial submissions, Variations, and full Lifecycle Management deliverables for the global markets. They will also possess strong analytical skills, attention to detail, and excellent communication skills.

Key Responsibilities:
  • Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Review technical documents from manufacturing sites, including Specifications, Batch Manufacturing Records, Process & Analytical Validations, Batch Analysis Data, and Stability Data.
Required Skills and Qualifications:
  • Minimum 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for the global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.
Benefits:

This role offers the opportunity to work in a dynamic and growing company, with a competitive salary and benefits package. You will also have the chance to develop your skills and knowledge in Regulatory Affairs, and contribute to the success of our team.

As a Regulatory Affairs Specialist, you will be responsible for ensuring that our products meet the highest standards of quality and safety. You will work closely with our cross-functional teams to identify and mitigate risks, and implement corrective actions as needed.

Others:

Please note that this is not an exhaustive list of responsibilities, and other tasks may be assigned as needed. We are committed to ongoing training and development, and offer opportunities for growth and advancement.

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