
Regulatory Compliance Expert
10 hours ago
The Regulatory Compliance Role is a high-profile position that requires strong leadership and management skills to oversee regulatory affairs activities at the manufacturing site. The successful candidate will ensure timely regulatory submissions, compliance with regulations, and provide strategic support to business operations.
Main Responsibilities:
- Prepare and submit various applications such as product permissions, facility modifications, technical approvals, test licenses, amendments in licenses, state GMP and GLP certificates, and post-approval changes to State FDA.
- Evaluate technical and scientific data for regulatory submissions and liaise with health authorities for inspections, clarifications, and approvals.
- Maintain regulatory databases, trackers, licenses, and approvals, and review and track regulatory impact of quality documents.
- Obtain necessary certifications and documents to support business operations, coordinate documentation and facilitate site inspections, and deliver training on GMP and regulatory updates.
Key Skills:
- Strong leadership and management skills
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Strong analytical and problem-solving skills
- Familiarity with regulatory requirements and industry standards
What We Offer:
- A dynamic and challenging work environment
- Opportunities for professional growth and development
- A competitive compensation package
- A collaborative and supportive team
About Us:
We are a leading manufacturer of pharmaceuticals and we are committed to delivering high-quality products to our customers. We are looking for a highly skilled and motivated individual to join our team as a Regulatory Compliance Expert.
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