Are you a skilled Regulatory Affairs professional looking to make a meaningful impact in the pharmaceutical industry? Rusan Pharma invites you to join our dedicated team in Mumbai (Kandivali) as an Officer/Executive in Regulatory Affairs.
About Rusan Pharma
Rusan Pharma is a leading pharmaceutical company specializing in life-saving drugs. With a commitment to quality, innovation, and regulatory excellence, we serve global markets across CIS (Commonwealth of Independent States) and ROW (Rest of the World) regions. At Rusan Pharma, we focus on compliance, teamwork, and fostering an environment where every employee contributes to making healthcare accessible.
Responsibilities in the Role
As an Officer/Executive in the Regulatory Affairs team, you will:
- Prepare and submit dossiers for product registration in CIS and ROW markets.
- Handle registration dossiers for prequalification processes in CIS and ROW regions.
- Coordinate with manufacturing sites to ensure seamless regulatory submissions.
- Arrange and manage registration samples from manufacturing sites and address related queries.
- Review and verify artworks as per country-specific requirements.
- Maintain tracker sheets for monitoring regulatory status, including registration, submissions, and targeted timelines.
- Oversee serialization and commercial verification processes.
Qualification and Experience
- Educational Background: Bachelor’s or Master’s degree in Pharmacy.
- Experience: Minimum of 3 years in the Regulatory Affairs department, particularly in pharmaceutical regulatory submissions for CIS and ROW markets.
Essential Skills
- Strong leadership, communication, and interpersonal skills.
- Proven problem-solving and analytical abilities.
- Comprehensive knowledge of pharmaceutical industry regulations and guidelines.
- Proficiency in Microsoft Office Suite and project management tools.
Please drop your updated CV on pooja.thakur@rusanpharma.com
