Regulatory Affairs Specialist

Regulatory Affairs Specialist is needed to perform the following duties: 

o    Prepare, review, and submit regulatory submissions to the FDA including NDA’s and ANDA’s.

·         Assist in developing and implementing submission strategies for NDA (both 505(b)1 and 505(b)2) and ANDAs

·         Assist in planning, writing and review of all regulatory submissions to support original IND, 505(b)1, 505(b)2, ANDA

·         Assist in submissions including FDA meeting requests and packages

·         Review DMFs and coordinate with external vendors to obtain regulatory documents to support project activities.

·         Maintain open, timely and effective communications with cross-functional teams to ensure timely delivery of documents required for the application

·         Review submission documentation and provide input to respective departments for necessary revisions.

·         Coordinate and prepare responses to FDA Deficiency Letters and other agency requests.

o    Create, revise, proofread, and approve all labeling components, including package inserts, medication guides, patient/pharmacist information inserts, container labels, and cartons, based on RLD labeling in conjunction with applicable regulatory guidance.

·         Monitor labeling updates for both approved products and under review products.

·         Review and proofread artwork at various stages of routing and approval to ensure accuracy, consistency, and quality.

·         Assess labeling artwork for compliance with regulatory requirements and internal procedures and policies.

·         Route labeling artwork for approvals and obtains signatures from cross-functional roles per specified procedures and forms.

·         Maintain, catalog, and retain all labeling materials in accordance with company policies and procedures.

·         Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising, labeling and promotion of pharmaceutical products.

o    Assist in developing regulatory strategies for all Chemistry, Manufacturing and Controls (CMC) changes post approval and submit necessary post approval supplements when required.

·         Review, assess and develop strategies with cross-functional teams for CMC-related changes

·         Provide regulatory guidance/perspective to cross-functional teams

·         Determine regulatory, scientific, and technical requirements for CMC- and GMP-related submissions and inquiries

·         Prepare, coordinate, all CMC- and GMP-related documents for submission to regulatory authorities to assure compliance with regulatory, company standards, and scientific/technical requirements

·         Provide regulatory assessment in change management and provide appropriate reporting category.

·         Assist in completion of post marketing commitments & relevant lifecycle management including but not limited to Annual Reports, Quarterly and Annual Periodic Adverse Drug Experience Reports, etc.

·         Monitor continuously for labeling updates for all approved products and ensure timely submission of labeling supplements

·         Coordinate with cross functional teams and external vendors for the timely receipt of documents necessary for submission to the health authority.

·         Maintain, catalog, and retain all post approval submissions in accordance with company policies and procedures.

·         Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents

·         Compile, integrate and publish submission documents with word processing, electronic publishing, and document management systems

·         Monitor new and updates to regulatory policies and guidance relating to electronic submissions.

·         Monitor continuously for labeling updates for all approved products and ensure timely submission of labeling supplements

·         Follow up with the health authorities for the timely approval of all labeling amendments/submissions.

·         Convert all approved labeling material into SPL format

·         Review and proofread SPL and ensure timely submission to the health authorities consistent with regulatory guidelines and policies.

o    Prepare and submit Annual Reports, Labeling Supplements, Quarterly and Annual Periodic Adverse Drug Experience Reports, etc.

o    Organize and maintain submission components associated with a regulatory submission electronically

o    Prepare, review, and submit drug listing in SPL format using pharmaReady/XForms. Prepare and assist in submitting promotional materials to the Regulatory Agency.

Bachelor Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science