Please note that the requirements specified in this posting are the basic qualifications required for the Director position; however, job title will be dependent on the candidate's level of experience in those requirements.
- Provides regulatory oversight for multiple projects covering a minimum of one highly active therapy area, focused on non-clinical and clinical aspects of drug development and associated regulations.
- Provides leadership and training for multiple direct reports including those that serve as GDT regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
- Collaborates with all Takeda regional counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility.
- Oversee regulatory guidance feedback to competent authorities and provide interpretation to the business
- Oversees GDT regulatory leads within staff responsible ensuring global regulatory strategies are written and executed according to plan.
- Oversees multiple projects, generally has global oversight for compounds in a minimum of one disease area.
- Oversees and accountable for all relevant submissions and approvals within therapeutic area of responsibility for assigned programs.
- Oversees and accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local Takeda affiliates within therapeutic area of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- In collaboration with global affairs, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables outside of region as agreed within the global regulatory strategy. Approves global regulatory strategies and authors for more complex regulatory strategies as needed; over see execution, generally delegates to staff.
- Supervises multiple direct reports. Manages, trains and provides oversight for staff day-to-day activities.
- Leads and manages meetings with regulatory authorities and agency meetings; or delegates and oversees direct reports; negotiates on behalf of project team as necessary.
- Lead interactions with health authorities, delegate to staff for general interactions.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Manages personnel within group to ensure coverage for project and therapy area(s) responsibilities; Elevates needs when necessary
- Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Presents to senior management.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc. Advanced scientific related degree preferred; BA accepted based on experience.
- Advanced degree preferred
- A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience.
- Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; global involvement also preferred.
- Experience in managing personnel required.
- Solid working knowledge of drug development process and regulatory requirements; knowledge of Americas, EU, Canada, ROW, and post-marketing a plus.
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
- Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Generally strong in working well with others, within global teams and communicating with senior leadership.
- Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
- 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.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 20 % travel.
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