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Post : Associate, Global CMC Regulatory Affairs
Job Description
• Supports global regulatory filings for development compounds and marketed products in collaboration with/under supervision of other senior level CMC RA personnel.
• Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions.
• Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.
• May assist in providing accurate regulatory assessments of CMC changes for execution of regulatory planning and implementation.
• Provides input to assist in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
• Assists with CMC RA submissions for renewals, annual product submission, and questions from LOC partners/health authorities/other JNJ partners.
• Works other CMC RA personnel to assure compliance with local regulatory requirements and commitments per the Global Regulatory Team
• Contributes to the implementation of global CMC regulatory strategies and dossier plans for development compounds and marketed products.
• Assists in execution of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Assists in execution of the regulatory CMC strategy for Health Authority responses as needed.
Candidate Profile
• BS in engineering, biological, pharmaceutical, or chemical sciences with generally a minimum of 4+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience. MS., Ph.D, or Pharm. D. degree preferred
• Prior drug development, analytical development, or manufacturing experience.
• Good verbal and written communication skills. Good organizational skills. Strong attention to detail.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
• General knowledge of global HA laws, regulations, and guidances.
• Understanding of product development.
• Solid understanding of biology, chemistry, and/or engineering relevant to therapeutic area.
• This position will be based in Titusville, NJ or Spring House, PA and requires up to 5% travel, both international and domestic.
Additional Information:
Experience: 4+ years
Qualification: BS
Location: Titusville, New Jersey; Spring House, Pennsylvania
Functional Area: Regulatory Affairs
Industry Type: Pharma
Requisition ID : 6783180321
End Date: 30th April, 2018
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