Associate Director of Regulatory Affairs

Accord Healthcare Inc. is seeking an Associate Director of Regulatory Affairs - in Durham, North Carolina.  Oversee operations for Risk Evaluation and Mitigation Strategy (REMS) program components through collaborative partnerships with expert cross-functional representatives. Oversee and manage employees (3) within the regulatory affairs department to ensure operational quality, compliance with regulatory and business requirements, and inspection readiness. Ensure that all labeling, marketing literature, and internal policies and procedures are reviewed for compliance to regulatory requirements. Monitor FDA CDERNEWS and applicable web sites for new Orange Book listings, competitor Paragraph IV Certifications/Approvals and New Guidances, labeling updates that may impact pending/future ANDAs and provide impact on project/company. Oversee Labeling/Packaging, Re-Re-labeling/Re-packing components at Labeling Facilities and ensure completion. Maintain contact with the FDA on all issues related to labeling submission, Chemistry Manufacturing and Control submissions. Work cross functionality with Microbiology/Chemistry team and third-party validation consultants regarding assessment of in house stability test methods. Evaluate compendial/Non-compendial status and execute regulatory filing necessary to implement change.

Master’s degree (or foreign degree equivalent) in Agricultural, Crop Science, Life Science, Consumer and Environmental Science or related field of study, plus six (6) years of experience in the job offered or similar quality and regulatory affairs position. Must have six (6) years of experience in handling regulatory responsibilities pertaining to submission of documentation to FDA, implementing regulatory requirements in drug development, labeling, patent evaluation, and implementing regulations pertaining to drug products.

Travel required nationally and internationally up to 15% of time. 

Resumes to:      Attn: HR
Accord Healthcare, Inc.
1009 Slater Road, Suite 210B
Durham, NC 27703