Manager, Regulatory Consulting (CMC at Syneos Health in Remote
Responsible for leadership of major assignments and client relationships. In consultation with the line manager, responsible for contributing to project teams as a CMC Regulatory lead and for the quality and timeliness of assigned deliverables. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. Contributes to business development for regulatory functions.
Essential Functions:
Assists in authoring Chemistry, Manufacturing and Controls (CMC) sections of regulatory documents from source documents provided by the client, such as regulatory meeting briefing documents, module 2 sections, module 3 sections, and other relevant modules of regulatory applications (e.g., IND, IMPD, BLA, NDA, ANDA, MAA, supplements, variations) that are acceptable to regulatory authorities. Reviews customer documentation and/or regulatory dossiers for completeness and compliance with regulatory requirements and communicates assessment outcomes with clients. Acts as a key point of contact for clients and regulatory authorities. Interacts professionally at multiple levels within a client organization to communicate recommendations, obtain necessary information, provide status or updates to project deliverables. Manages timelines and resources for regulatory submission projects to meet client's expectations. Arranges, leads, and reports on client and regulatory agency meetings. Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents. Contributes to process improvement and experience sharing efforts within Global Regulatory Consulting (GRC). Acts as a representative of the CMC Regulatory consulting group with other functional teams or the GRC with other departments. Supports business development, including generation of repeat business from existing clients and proposal development. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees. Other
Responsibilities:
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Qualifications Requirements:
Along with demonstrated initiative, uncompromising integrity and a results-oriented mindset, the ideal candidate has:
BS degree or above, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/biologic/medical device related experience and comprehensive understanding of pharmaceutical product development. Experience with biological drug development and submissions is a plus. Moderate experience in regulatory relating to CMC, including but not limited to knowledge and application of relevant statutes, regulations and guidance, and product and process analytics, specifications, comparability, and stability.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Essential Functions:
Assists in authoring Chemistry, Manufacturing and Controls (CMC) sections of regulatory documents from source documents provided by the client, such as regulatory meeting briefing documents, module 2 sections, module 3 sections, and other relevant modules of regulatory applications (e.g., IND, IMPD, BLA, NDA, ANDA, MAA, supplements, variations) that are acceptable to regulatory authorities. Reviews customer documentation and/or regulatory dossiers for completeness and compliance with regulatory requirements and communicates assessment outcomes with clients. Acts as a key point of contact for clients and regulatory authorities. Interacts professionally at multiple levels within a client organization to communicate recommendations, obtain necessary information, provide status or updates to project deliverables. Manages timelines and resources for regulatory submission projects to meet client's expectations. Arranges, leads, and reports on client and regulatory agency meetings. Ensures Standard Operating Procedures are followed for adequate completion of regulatory documents. Contributes to process improvement and experience sharing efforts within Global Regulatory Consulting (GRC). Acts as a representative of the CMC Regulatory consulting group with other functional teams or the GRC with other departments. Supports business development, including generation of repeat business from existing clients and proposal development. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees. Other
Responsibilities:
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Qualifications Requirements:
Along with demonstrated initiative, uncompromising integrity and a results-oriented mindset, the ideal candidate has:
BS degree or above, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/biologic/medical device related experience and comprehensive understanding of pharmaceutical product development. Experience with biological drug development and submissions is a plus. Moderate experience in regulatory relating to CMC, including but not limited to knowledge and application of relevant statutes, regulations and guidance, and product and process analytics, specifications, comparability, and stability.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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