Regulatory Affairs Manager

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.
• Responsible to get the necessary documents which are going to be useful for registration purpose.
• Usually, this registration application is done online, and you need to constantly keep a follow up with the regulatory team.
• Responsible to liaise with the authority daily based on the requirements pertaining to document for the smooth transition with the regulator and submit regularly to the regulating authority to get the registration executed in a timely manner.
• Front lining the entire process with respect to coordination with Originator, regulatory authority and in need be travel to Delhi for meetings.
• The company has tied up with an agency to make sure there are no gaps and you will be responsible to liaise with the Agency who closely work with the government authority to satisfy the documentation requirements.
• You will be also responsible to regularly interact and funnel the requirements with the agencies and the regulatory authorities.
• 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.

Requirements:

Skills and Qualifications

• 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.

Experience

• 7–8 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.