Regulatory Affairs Lead, Marketed Products, Gem

**_ OBJECTIVES/PURPOSE_**
- Directly manage and develop staff members, provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable.
- Provide vendor oversight, program/project management and leadership to ensure successful management of regulatory activities under the relevant agreements with a vendor(s).

**_ ACCOUNTABILITIES _**
- Collaborates to define, develop and lead Marketed Products GEM 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 Marketed Products GEM 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
- Evaluates new business development opportunities for Growth and 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 Marketed Products GEM in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required
- Manages, trains, provides 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
- Responsible for demonstrating Takeda leadership behaviors

**Decision-making and Autonomy**
- _ Take initiative and coordinate resources to drive tasks to deadlines_
- _ Demonstrate technical and solutioning skills, influence decision making to feasible solutions_
- _ Use collaboration skills and partnerships to work within the agreed Governance model_

**Interaction**
- _ Confidently engage with external vendors and manage internal stakeholders, representing the needs of the BU_
- _ Express self clearly and concisely at all levels, in both verbal and written communication_
- _ Demonstrate maturity of thinking_
- _ Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement_
- _ Create and deliver clear and professional presentations with appropriate messaging and focused recommendations _

**Innovation**
- _ Foster a culture of best practice and knowledge sharing_

**Complexity**
- _ Understand the changing needs and priorities of the business_
- _ Understand complex issues and to propose timely, cost-effective and achievable solutions, whilst being mindful of flexibility rather than a “one size fits all” approach_
- _ Work in a fast-paced environment with demonstrated ability to delegate and juggle multiple competing tasks and demands, often with a degree of ambiguity_
- EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: _
- Bachelor’s degree in a scientific discipline; BA accepted based on experience. Advance degree preferred.
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases
- 10 years of directly related regulatory experience is desirable
- Sound working knowledge of regulations and guidance governing drugs and biologics in development and life-cycle management for growth and emerging markets; 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 is able to bring working teams together for common objectives
- Experience managing relationships with CROs and/or contractors is also preferred

**_ ADDITI