Executive – Regulatory Affairs
Job Summary:
Sovvaka Global is seeking a highly motivated and detail-oriented Executive – Regulatory Affairs to join our growing team in Mumbai. This role is an excellent opportunity for a B.Pharm or M.Sc graduate with 1-3 years of experience in regulatory affairs to contribute to a fast-paced pharmaceutical organization. The successful candidate will be responsible for preparing, reviewing, and submitting regulatory dossiers, ensuring compliance with regulations, and supporting various regulatory submissions.
Job Summary
The Executive – Regulatory Affairs will play a critical role in ensuring that our products comply with all applicable regulatory requirements. This position involves the preparation, review, and submission of regulatory dossiers, as well as continuous monitoring of updates in drug regulatory policies and guidelines. The ideal candidate will possess a strong understanding of regulatory affairs, excellent communication skills, and the ability to work effectively with cross-functional teams.
Responsibilities
- Prepare, review, and submit regulatory dossiers in accordance with global and domestic guidelines.
- Ensure compliance with regulatory standards, documentation formats, and timelines.
- Coordinate with cross-functional teams to collect data and ensure technical accuracy of submissions.
- Support regulatory submissions for new products, renewals, variations, and post-approval documentation.
- Maintain regulatory archives and ensure documentation is audit-ready.
- Monitor updates in drug regulatory policies, guidelines, and market requirements.
- Assist in the preparation and management of responses to regulatory inquiries.
- Maintain up-to-date knowledge of relevant regulations and guidelines.
- Participate in internal audits and inspections to ensure compliance with regulatory requirements.
- Contribute to the development and improvement of regulatory processes and procedures.
Requirements
- Qualification: B.Pharm or M.Sc (Pharmaceutical Sciences, Chemistry, or related fields).
- Experience: 1-3 years of relevant experience in regulatory affairs.
- Location: Mumbai, India
- Strong understanding of Regulatory Affairs, dossier preparation, and product compliance.
- Excellent communication (written and verbal) and documentation skills.
- Ability to work independently and as part of a team.
- Detail-oriented with strong organizational skills.
- Proficiency in Microsoft Office Suite.
- Knowledge of relevant regulatory guidelines and regulations (e.g., ICH, FDA, EMA).
Benefits of Working with Sovvaka Global
- Competitive salary based on experience and qualifications.
- Opportunity to gain exposure to a wide range of regulatory submissions.
- Work alongside experienced regulatory professionals and learn from their expertise.
- Enhance your skills in compliance, documentation, and regulatory strategy.
- Growth potential within a rapidly expanding pharmaceutical company.
- A supportive and collaborative work environment.
- Opportunities for professional development and training.
How to Apply
If you are a qualified and enthusiastic professional seeking an exciting opportunity in regulatory affairs, we encourage you to apply. Please submit your updated CV and a cover letter outlining your relevant experience and qualifications to [email protected]. We look forward to hearing from you.