- As the RA CMC lead on Pharmaceutical Development and Regulatory project teams, independently develops and leads the execution of regulatory CMC development strategies for innovative First-In-Human and early stage products (pre IND, Phase 1, Phase 2).
- Demonstrates leadership and comprehensive understanding of global RA CMC regulations and guidelines.
- With limited supervision, successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
- Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
- Provides regulatory CMC expertise for new business development/due diligence activities.
- Independently plans, executes and manages regulatory submissions for assigned early-stage development compounds.
- Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization. Stays abreast of current and evolving regulatory CMC requirements.
- Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
- Lead team members that define CMC content (data and documentation) requirements for regulatory submissions.
- With limited supervision, represents Takeda RA CMC in Health Authority meetings and leads preparation activities for meetings with Health Authorities on CMC related matters.
- 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. Provides solutions to prevent recurrence of issues.
- Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
- Evaluate new business development opportunities or participate on due diligence teams
- Evaluates change proposals for global regulatory impact and plans global variations and amendments.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up and/or regulatory registration of products is required.
- Experience with global regulatory aspects of CMC involving undefined frameworks and technical complexity.
- Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings. International experience preferred.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- 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 values teamwork.
- Demonstrated ability to work well within a matrix structure in a complex environment.
- Exercises good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
- Excellent written and oral communication skills required.
- Active participation in Agency/Industry groups/forums preferred.
- Routine demands of an office based environment.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Requires approximately < 10% travel.