- Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
- Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
- The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
- 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.
- Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types.
- Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
- Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
- Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
- Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
- Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
- Responsible for demonstrating Takeda leadership behaviors
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BSc Degree, preferred. BA accepted.
- 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
- Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence 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.
- Must work well with others and within global teams.
- Able to bring working teams together for common objectives.
- Acceptable and independent skills 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.
- 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, including overnight trips.
- Requires approximately up to 10-30% travel.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.