Head Regulatory Affairs Emerging Markets

**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the pharmaceutical industry? Takeda, a global leader in the field of healthcare, is seeking an exceptional regulatory affairs leader for the position of **_Head Regulatory Affairs Vaccines Emerging Markets (M/F/d)_**. This is a unique opportunity to make a significant impact on the development and regulatory strategy of our vaccine portfolio across emerging markets. **Key Objectives of the role**: - Develop and communicate the optimal regional regulatory strategy for the Vaccine Business Unit, aligned with global development goals. - Oversee all regional regulatory strategy and activities for the entire vaccine portfolio, including Health Authority meetings. - Manage relationships and communications with the Regulatory Affairs Local Operating Companies (RA LOCs), Pharma Regional Group Emerging Markets (GEM) Business Leads and Regional GEM GRA Leads and represent Regulatory Affairs Vaccines (RAV) in regional business units. - Provide strategic regulatory guidance for developmental and marketed vaccines within the region. - Build and lead a highly functioning regional regulatory team focused on vaccines. - Represent regional regulatory strategy at Global Project Team (GPT) meetings and engage with Executive Leadership. - Stay informed about regulatory trends and policies that could impact the Vaccine Business Unit by interacting with trade organizations and industry groups and Takeda regulatory policy groups. **Accountabilities**: - Create the optimal emerging markets regional strategy for global regulatory development of Takeda vaccine products. - Oversee and ensure timely submission of high-quality regulatory documents and oversee regulatory interactions. Serve as the vaccine regional regulatory representative for specific projects or marketed vaccines. - Manage regional product development resources, including consultants and budgets, to support efficient operations. - Prepare reports, strategy documents, and presentations outlining regional vaccine development and licensure activities. - Foster ongoing and proactive relationships with vaccine regulatory authorities. - Conduct "due diligence" and feasibility assessments, as assigned. - Manage, develop, and hire regional vaccine regulatory associates, as required. **Your Profile**: - Bachelor's degree or equivalent in a scientific discipline; advanced degree preferred. - 10 years of pharmaceutical experience, with a focus on vaccines preferred. - 10-12+ years of direct regulatory affairs experience, preferably in the vaccines field. - Experience in working with Emerging Markets region a must - Understanding of international regulatory requirements and complexities and ability to determine most efficient way to regulatory success - Previous management experience. - Strong regulatory judgment across multiple filings. - Ability to interpret complex scientific issues related to vaccine regulatory requirements and strategy. - Proven track record of successfully licensing pharmaceutical products. - Excellent interpersonal, mentoring, and leadership skills. - Cross-cultural awareness and experience in working within a global environment. - Proficient in oral and written communication across all levels of the organization. - Effective in managing timelines, negotiation skills, and adaptability. - Ability to develop staff in regulatory strategy, identify issues, and offer creative solutions. **What you can look forward to with us**: - Appreciative working atmosphere in an international and exciting working environment - Independent work with the opportunity to play a part in shaping an innovative company - Professional and personal development opportunities - Flexible working hours and home office **Empowering our people to shine** **Diversity, Equity and Inclusion** Takeda is committed to foster diversity, equity and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age or disability. If you are seeking a challenging leadership role where you can drive regulatory strategies and make a tangible impact in the vaccines space, we encourage you to apply. Join Takeda and contribute to our mission of improving the health and well-being of patients worldwide **Locations**: Zurich, Switzerland **Worker Type**: Employee **Worker Sub-Type**: Regular **Time Type**: Full time