- Defines, develops and leads Growth & Emerging Markets strategies to maximize regulatory success to strengthen the product development plan, to enable patient access and to achieve appropriate price and reimbursement in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management.
- Directly manage staff members, provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable.
- Responsible for demonstrating Takeda leadership behaviors.
- Defines, develops and leads Emerging Markets strategies to maximize regulatory success towards achievement of program objectives.
- Independently manages, plans and directs all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program.
- Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.
- Stays current with regulations/guidances in Growth & Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
- Provides regulatory expertise on Growth & Emerging Markets for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of drug development, registration and / or post-marketing compliance and life cycle management.
- Assures ongoing efforts towards fulfillment of international product approval conditions for late stage programs. Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company s consultants and Business Partners.
- Supports Access to Medicines initiatives to develop and implement innovative patient access strategies.
- Evaluates new business development opportunities for Growth & Emerging Markets and / or participates on due diligence teams.
- In coordination with local regulatory lead provides strategic guidance / advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
- Oversees interactions with Health Authorities in Growth & Emerging Markets countries for all programs in defined Therapeutic Area scope. Provides interpretation to the business, Global Product Lead and other key stakeholders;
- Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents Takeda Emerging Markets in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required.
- Has an established Rapport with Global Health Authorities that enables constructive exploratory discussions.
- Provides leadership and training to direct reports and / or mentors team members, if required, to support scope of project work.
- Partner with the regional/LOC market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/Health Agency on value and evidence topics and to support Heath Authority decision making.
NUMBER SUPERVISED WORKERS:
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred.
- Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.
- 10 years of directly related regulatory experience is desirable.
- Solid regulatory experience, including knowledge of regulations and guidances governing drugs and biologics in all phases of development for emerging markets and US and/or EU (relevant to role) as well as leading interaction with Health Authorities.
- Preferred experience in managing multiple filings; or managing multiple programs across therapy areas in closely related development area; global involvement also preferred. Must be able to provide guidance in interpreting regulatory regulations and guidelines. Must be able to formulate global regulatory strategy to achieve competitive and accelerated product approvals.
- Solid understanding and ability to interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
- Must be strong overall and able to train/develop staff in 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 all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Generally strong in working well with others, within global teams and communicating with senior leadership.
- Inspires and motivates group. Takes stand on important issues in productive, respectful way.
- Experience in managing personnel required; preferred experience in managing multiple personnel for multiple years as well as experience managing relationships with CROs and/or contractors.
- 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.
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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.
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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.