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Regulatory Affairs Specialist
2 weeks ago
Whitecrow Research is a global talent research, insight, and pipelining specialist with international reach. We help clients understand and penetrate specialist markets worldwide.
We specialize in supporting companies within the healthcare sector by providing marketing and commercial solutions across Southeast Asia and India.
The current job opportunity is with a multinational company operating in Southeast Asia, the Middle East, and North Africa with a plan for global expansion. Their main focus is on sales, marketing, and distribution of pharmaceuticals, medical devices, diagnostics, and over-the-counter products.
Key Responsibilities:
- Ensure all products comply with applicable laws, regulations, and standards as per Indian law.
- Stay updated on regulatory changes and assess their impact on the company's products or processes.
- Prepare or coordinate regulatory documents such as dossiers, technical files, and applications for product approval or licensing.
- Follow up with regulatory agencies to get approval of medical devices/pharmaceutical products.
- Work with 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 teams on regulatory requirements.
Requirements:
- Bachelor's degree in a related field. An advanced degree is an advantage.
- Strong knowledge of regulatory requirements and global standards.
- 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:
- 7-10 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.
Target Industry: Medical Device
