Senior Manager, Regulatory Affairs, Rare Genetics

**POSITION OBJECTIVES**:
**POSITION ACCOUNTABILITIES**:

- Collaborates to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives.
- Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.
- Provides regulatory expertise on 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 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.
- Evaluates new business development opportunities for 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.
- 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. Effectively communicates and manages meeting outcome and next steps, as required.
- Manages, trains, provide direction, strategic guidance and solutions to projects 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 understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
- Collaborate with GEM RLs and Japan-Asia sub-group for assigned programs as Japan-Asia Regulatory Lead
- Cooperate with key stakeholders in GEM BU in supporting GEM initiative activities to meet the organizational objectives and requirements.
- Support GEM RA Head for assigned tasks

**EDUCATION, EXPERIENCE AND SKILLS**:

- BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred.
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
- 6 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.
- 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.
- Effective manager who can bring working teams together for common objectives.
- Experience managing relationships with CROs and/or contractors also preferred.

**TRAVEL REQUIREMENTS**:

- Requires approximately up to 10-30% travel.

**Locations**:
Singapore, Singapore

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time