Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows:
This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows
Roles & Responsibilities: - With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
- RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
- Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.
- bility to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
- Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
How you will contribute: - With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s)
- Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges.
- With supervision, supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
- Interacts directly with international Health Authorities on administrative procedural topics, as required.
- Fosters constructive working relationships when interacting with internal and/or external colleagues.
- Evaluates change proposals for global regulatory impact with some supervision.
- s a RA CMC member, ensures and/or enhances regulatory compliance .
- 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.
Minimum Requirements/Qualifications: - BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA . Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
- nalyze issues with attention to detail.
- bility to assess alternative approaches.
- Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
- ble to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
- Understands who is responsible for different decisions and escalates as necessary
- pplies decisions taken by the company
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
- Intentionally promotes an inclusive culture
- pplies the given prioritization framework with limited support
- Excellent written and oral communication skills required.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
