
Regulatory Affairs Specialist
2 days ago
Regulatory Affairs Specialist
">The Regulatory Affairs team is seeking a highly skilled and experienced specialist to support the management of regulatory submissions for healthcare products across diverse geographies.
">Key Responsibilities:
">- Management and coordination with vendors of technical and legal requirements for obtaining marketing authorization approval at health authorities in Latin America countries;
- Pre-audit and audit of dossiers for new product applications from India to be submitted in Latin America countries;
- Strong follow-up with vendors by email, phone, or personal meetings to ensure timely delivery of technical and legal documents required to comply with regulatory plans;
- Coordination of regular meetings between internal RA teams and vendor RA teams to track ongoing projects;
- Coordination with vendors for the shipment of samples and original hard copies of documents required for submission in each country;
- Development of special requirements such as transport validations, in vivo or in vitro bioequivalences to comply with regional regulations;
Requirements:
">- Proven experience in handling portfolio submissions from a regulatory affairs standpoint, including evaluation of multiple contractors;
- Strong communication and collaboration skills;
- Demonstrated ability to work independently with a results-driven approach;
What's On Offer:
">A dynamic and agile work environment that fosters innovation, growth, and rapid development within the organization. Employees are encouraged to take ownership, innovate, and grow rapidly.
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