Defines, develops and leads Emerging Markets strategies to maximize regulatory success to strengthen the product development plan and to enable patient access in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management as well as. Directly manage staff members, provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable.
- Collaborates to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives.
- Manages, plans and executes the 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/guidance's in 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 Emerging Markets for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of registration and/or post-marketing compliance and life cycle management.
- Assures ongoing efforts towards fulfilment 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.
- Provides regulatory input to the evaluation of new business development opportunities for Emerging Markets.
- 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.
- 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.
EDUCATION, EXPERIENCE AND SKILLS:
- BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred.
- Sound experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases.
- 4 years of directly related regulatory experience is desirable.
- Sound working knowledge of regulations and guidance's governing drugs and biologics in development and life-cycle management for emerging markets; and US and/EU (relevant to role), including interaction with Health Authorities.
- Experience with external partners
- Leading cross-functional teams in regulatory submissions
- Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Able to demonstrate skill(s) 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 working well with others and within global teams.
- Experience managing relationships with CROs and/or contractors is desirable.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations
Massachusetts - Virtual Worker Type
Employee Worker Sub-Type
Regular Time Type