Regulatory Affairs Specialist
5 days ago
About our client are global talent research, insight and pipelining specialists with offices in various locations. Their international reach has helped them understand specialist markets at a global level.
Our client specializes in supporting companies within the healthcare sector by providing marketing & commercial solutions across regions. The current job opportunity is with a Singapore based, healthcare multi-national company with operations in regions with established plans for expansion. Their main focus is on sales, marketing and distribution of Pharmaceutical, Medical Devices, Diagnostics & OTC products.
Job Description:As a Regulatory Affairs Specialist, you will be responsible for ensuring all products comply with applicable laws, regulations, and standards. This includes staying updated on regulatory changes and assessing their impact on the company's products or processes.
You will prepare or coordinate with originator review and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing. Necessary follow-ups with regulatory agencies to get approval of medical devices/pharmaceutical products are also part of your responsibilities.
You will work closely with Originator and marketing teams to ensure product alignment with regulatory requirements. Leading or assisting in regulatory audits conducted by agencies or certification bodies is another key responsibility.
Identifying and mitigating regulatory risks that could impact product approvals or market access are essential skills required for this role. Developing and implementing regulatory strategies to accelerate market entry and ensure sustained compliance are critical tasks.
You will conduct training sessions for cross-functional teams on regulatory requirements and best practices.
- Bachelor's degree in a related field
- 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
This position requires 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 is highly desirable.
Benefits:The target industry is Medical device. Location: Delhi.
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