Regulatory Affairs Professional
1 week ago
Job Title: Regulatory Affairs Professional
We are seeking a highly experienced regulatory professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring adherence to applicable regulations.
- We need someone with a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
- The ideal candidate will have experience with regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
Key Responsibilities:
- Prepare, review, and submit regulatory filings for new products.
- Evaluate and ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
About This Role:
This position requires a unique blend of technical expertise, business acumen, and communication skills. The successful candidate will be able to effectively navigate complex regulatory landscapes, build strong relationships with stakeholders, and drive business growth through strategic planning and execution.
What We Offer:
In addition to a competitive salary and benefits package, we offer a dynamic work environment that fosters innovation, creativity, and collaboration. Our team is passionate about making a positive impact on the industry, and we're looking for like-minded individuals to join us on this journey.
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