Salvavidas Pharmaceutical Pvt. Ltd. is a Surat-based pharmaceutical company that specializes in the development, production, and marketing of pharmaceutical products. Known for its commitment to quality and innovation, Salvavidas aims to provide affordable and effective healthcare solutions across multiple markets. The company focuses on both domestic and international markets, ensuring compliance with various regulatory standards worldwide.
Responsibilities of the Regulatory Affairs Executive
As a Regulatory Affairs Executive at Salvavidas Pharmaceutical Pvt. Ltd., your key responsibilities will include:
- Preparing, compiling, and submitting regulatory documents to health authorities such as the FDA, EMA, and MOH for product approvals, renewals, and variations.
- Ensuring that all submissions are accurate, complete, and submitted on time in compliance with local, national, and international pharmaceutical regulations.
- Liaising with health authorities and regulatory agencies to streamline and facilitate product approvals.
- Keeping up-to-date with changes in regulatory guidelines and advising relevant departments of their impact.
- Managing the registration of new products across different markets.
- Collaborating with various departments like R&D, quality assurance, manufacturing, and marketing to ensure all products meet the required regulatory standards.
- Monitoring the regulatory environment to assess the impact of new regulations on the company’s product portfolio.
- Maintaining and updating regulatory documentation, including technical files and product dossiers.
Required Skills for the Role
To excel in this role, candidates must possess the following skills:
- Strong understanding of the regulatory market and compliance requirements across different regions.
- Analytical skills to interpret regulations and apply them effectively to product submissions.
- Excellent time management skills to handle multiple submissions and regulatory projects simultaneously.
- Strong problem-solving abilities to address regulatory challenges and resolve compliance issues.
- Attention to detail, ensuring that all submissions are accurate, compliant, and free of errors.
