- Develop and communicate optimal regional regulatory strategy for the Vaccine Business Unit (VBU), taking into account global development goals.
- Oversee all regional regulatory strategy and regulatory activities for the entire vaccine portfolio, including Health Authority meetings.
- Provide regional regulatory strategic guidance on all developmental and marketed vaccines.
- Develop a highly functioning regional regulatory team specific to vaccines.
- Represent regional regulatory strategy at GPT meetings and with Executive Leadership
- Interact with trade organizations and industry groups to identify regulatory trends and policy that could affect VBU.
- Accountable for development, approval and implementation of the regional regulatory strategy according to timelines for all vaccine candidates and vaccine products in region.
- Accountable for developing the optimal regional strategy for global regulatory development of Takeda vaccine products.
- Accountable for all regional regulatory submissions and oversight of regulatory interactions in the region.
- Act as and/or oversee the regional regulatory point person for global project team(s). The ability to function as global regulatory leader, expert in regional regulations, is one of the key distinguishing factors for this position.
- Serve as the regional regulatory representative for specific development projects or marketed vaccines, as assigned.
- Manage regional product development resources including consultants and budgets, as required and reflective of good company stewardship.
- Prepare periodic reports, strategy documents and presentations detailing Regional vaccine development and licensure activities.
- Oversee the development of ongoing and proactive relationships with vaccine regulatory authorities.
- As assigned, responsible for due diligence and feasibility assessments.
- Manage/develop/hire regional vaccine regulatory staff.
EDUCATION, EXPERIENCE AND SKILLS:
- BS degree or equivalent in a scientific discipline; advanced degree preferred
- 10+ years pharmaceutical experience, vaccine-specific preferred
- 10-12+ years direct regulatory affairs experience (vaccines experience preferred)
- Proven success licensing pharmaceutical products
- Excellent regulatory judgment across multiple filings
- Understands and interprets complex scientific issues across projects as they relate to vaccine regulatory requirements and strategy
- Previous management experience
- Excellent interpersonal, mentoring and leadership skills
- Adept at exhibiting cross-cultural awareness and working in a global environment
- Strong in all basic skills sets such as oral and written communication across all levels of the organization, managing and adhering to timelines, negotiation skills, integrity and adaptability
- Ability to develop staff in the area of regulatory strategy including on implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, define risk mitigation strategies.
- Ability to sit and stand for long periods of time
- Carrying, handling and reaching for objects
- Ability to lift and carry over 25 pounds
- Manual dexterity to operate office equipment i.e. computers, phones, etc.
Empowering Our People to Shine
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