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PharmSol Group, a globally recognized pharmaceutical services provider, is hiring a Regulatory Affairs Specialist in Hyderabad, Telangana. If you have a passion for pharmaceutical compliance, dossier preparation, and regulatory documentation, this opportunity offers a dynamic platform to grow your career in the global regulatory landscape.
PharmSol specializes in EU and US regulatory submissions, offering services spanning drug development, IPR, facility design, audits, registrations, and market access.
Key Responsibilities
- Prepare dossiers in eCTD format for regulatory submissions.
- Respond to queries received from regulatory authorities and stakeholders.
- Review and compile dossier review reports for received applications.
- Prepare Module 1 documents for regional submissions.
- Handle variation filings and ensure compliance with global regulatory standards.
- Manage MA transfer of approved products with respective authorities.
Qualifications & Skills
- M.Pharm in Pharmaceutics or Regulatory Affairs (mandatory).
- Strong communication and email drafting skills.
- Proficiency in project coordination and stakeholder communication.
- Ability to multitask and thrive in a fast-paced environment.
- Prior pharmaceutical industry experience preferred.
Benefits of Working with PharmSol Group
- Exposure to global regulatory frameworks (EU & US).
- Opportunity to work with cross-functional teams and international stakeholders.
- Competitive salary and professional growth in a compliance-driven organization.
- Access to continuous learning in Regulatory Affairs best practices.
How to Apply
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