Senior Manager, CMC, Global Regulatory Affairs
Nutley, NJ 07110 US
Target Pay Rate: 60-85/hr **salary will be commensurate with experience
As a Regional Regulatory CMC Senor Manager the incumbent will take ownership over the strategic and operational aspects of Regulatory CMC activities there assigned project(s) and lead on the Regulatory CMC submissions all the way from early development to the first successful BLA/ MAA. RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
- Develops and applies a comprehensive understanding of global RA CMC regulations and guidelines for biological products to assigned projects to enhance probability of regulatory success and regulatory compliance.
- With moderate supervision, successfully communicates and negotiates with Health Authorities as necessary, directly and indirectly. Develops constructive relationships with and proactively communicates issues to key internal and external colleague. Participates in identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes, leads development of company policy and positions on draft regulations and guidance.
- With minimal supervision, plans, executes and manages regulatory submissions for assigned products in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- As a RA CMC member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned products throughout development and the commercial life cycle. Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- With moderate supervision, represents RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
- Interacts directly with international Health Authorities, if required.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Fosters constructive working relationships when interacting with internal and/or external colleagues.
- Evaluates change proposals for global regulatory impact. and plans global variations and amendments.
- Development Projects 80%
- Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific background
- Identifies CMC regulatory issues and communicates them to the CMC team to mitigate risk
- Prepares original BLAs, MAAs and Growth Market dossiers ensuring that quality documents are prepared
- Tracks Module 3 leafs for global submissions
- Leads CMC authoring kick off meetings
- Interacts with and influences external stake holders
- Develops regulatory strategy
- Post Approval Projects 20%
- Prepares CMC content of post approval supplements and variations globally; annual reports, product renewals, notifications and change supplements.
- Tracks Module 3 leaf changes made as a result of post approval activity and submissions
- Leads CMC authoring kick off meetings. Guides authors regarding the necessary Module 3 updates
- Interacts with and influences external stakeholders
- Evaluates proposed post approval changes and develops the regulatory strategy
- Maintains Agency Approved Module 3 dossiers globally
- Minimum of a Bachelors Degree in a Scientific or Technical Discipline, with minimum 8+ years of experience in the pharmaceutical industry e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support for biological products
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
- Knowledge of CTD dossier (module 2.3 and 3).
- Able to deal with issues of critical importance with minimal supervision. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork
- Global organizational awareness
- Excellent written and verbal communication skills
- Leading change/innovative thinker
**CO/NY candidates may not be considered
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