Associate Director - Regulatory Affairs Vaccine (RAV) Europe

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

• Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.

• Manages assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region

• Ensures that all necessary applications are filed and maintained in compliance with applicable regulations. 

• Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.

• Responsible for regulatory oversight of assigned clinical trials conducted in the region.

• Collaborates with all Takeda regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.

• Passion for quality in all areas of responsibility

• Leads and directs the work of others as part of a matrixed organization.

• Close collaboration with the RAV Europe Region Head (and Local Operating Company (LOCs) RA as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.

• In cooperation with key stakeholders and RAV Europe Region Head (and LOC RA as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right-first-time.

• Supports overall content and management of local/regional regulatory components and filings e.g. MAA, MA variations. Contributes to local/regional label development and submission.

• Ensures compliance with both internal Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.

• Supports RAV Europe Region Head in the preparation of health authority interactions/meetings in the region as applicable for specified projects

• Actively participate as member of teams within RAV supporting activities as assigned.

• Manages specific projects as assigned.

• Responsible for assigned project/timeline planning and tracking of commitments.  Responsible for communication of commitments to team members.

Your profile:

• BS, advanced scientific degree preferred.

• A minimum of 8 years of pharmaceutical industry experience, with a minimum of 6 years of regulatory experience. 

• European regulatory experience is essential. Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval.

• Vaccines and/or biologics experience is preferred.

• Participation in Global regulatory filing is a plus.

• Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.

• Pays strong attention to quality, and is working reliably and thoroughly.

• Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.

• Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.

• Team player

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.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, 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 interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at  takedajobs.com

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