Head Regulatory Affairs Emerging Markets

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Job Description

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), PharmaRegional 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:

• Develop, approve, and implement the regional regulatory strategy for vaccine candidates and products in the region, ensuring adherence to timelines.
• 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

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world. Learn more at takedajobs.com.

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!

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