
Regulatory Affairs Professional
1 day ago
Job Overview:
We are seeking an experienced regulatory affairs professional to join our team in preparing, reviewing, and submitting regulatory documentation to global health authorities.
- The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
- The successful individual will be responsible for ensuring compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Develop and maintain regulatory strategies to support new product development and lifecycle management.
- Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Regulatory affairs expertise
- Strong knowledge of FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines
- Excellent communication and collaboration skills
As a key member of the team, you will play a critical role in ensuring the success of our products in the market.
About Us:We are a leading player in the industry, dedicated to delivering innovative solutions that meet the evolving needs of our customers.
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