Senior Manager/ Manager, Global Regulatory Affairs CMC - Biologics - United States
- Develops and leads the execution of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle with minimal supervision
- Develops and applies a comprehensive understanding of global RA CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance
- Manages interactions with international Health Authorities, successfully negotiating RA CMC matters, directly and indirectly.
- Develop constructive relations with key internal and external colleagues, including Alliance Partners.
- Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities with minimal supervision
- As a project team leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds 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 requirements
- Represents Takeda 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, as required.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
- Evaluates change proposals for regulatory impact and filing requirements
- Fosters constructive working relationships when interacting with internal and/or external colleagues
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 6 + years pharmaceutical Regulatory CMC experience. Alternatively, 4 + years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired.
- Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
- Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrates leadership, problem-solving ability, flexibility and teamwork
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills required
- Active participation in Agency/Industry groups/forums preferred
- RAC certification desirable but not mandatory
- Up to 30%
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs