Regulatory Affairs Manager
- Delhi
- Permanent
- Full-time
Our Client operates in the Pharmaceutical Manufacturing Industry, with its headquarters rooted strongly in Singapore. It has its branches spread to more than 5 countries, providing employment to 250 people. Their core business is to represent their client in countries that they do not operate in, and market/sell their products for them. They have achieved a wide client base in a very short time, and are looking for new talent.Responsibilities:
- Ensure all products comply with applicable laws, regulations, and standards as per Indian laws
- Stay updated on regulatory changes and assess their impact on the company's products or processes.
- Either prepare or coordinate with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.
- To do necessary follow-ups with regulatory agencies to get approval of the medical devices / pharmaceutical products.
- Work with Originator, and marketing teams to ensure product alignment with regulatory requirements.
- Lead or assist in regulatory audits conducted by agencies or certification bodies.
- Identify and mitigate regulatory risks that could impact product approvals or market access.
- Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.
- Conduct training sessions for cross-functional teams on regulatory requirements and best practices.
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering.
- Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage
- Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.)
- Excellent project management and organizational skills
- Ability to analyze and interpret complex regulations
- Proficient in regulatory writing and submission tools
- Strong communication and interpersonal skills
- Ability to manage multiple projects and meet deadlines.
- 7-10 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals
- Experience in handling registration of Medical Devices and getting approval.