Regulatory Affairs - Vaccines, Europe - Assoc. Director
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
What makes a successful member of our team?
We take action and make decisions by focusing on our four priorities in this order:
Putting the patient
at the center
Life at Takeda
To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.
Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Regulatory Affairs - Vaccines, Europe - Assoc. DirectorApply Now
Regulatory Affairs - Vaccines, Europe - Assoc. Director
Head Regulatory Affairs Vaccines (RAV) Europe
· Responsible for regulatory activities supporting the development and registration of vaccine candidates in Europe.
· Manages regulatory projects including Marketing Authorization Application (MAA) submissions for multiple vaccine candidates
· Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
· Leads and directs the work of others as part of a matrixed organization.
· Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
· Collaborates with all Takeda regulatory counterparts to ensure a global regulatory alignment for all projects within area of responsibility.
· Co-ordinates and is accountable for all Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time.
· Acts as primary regulatory authority contact for projects of responsibility.
· Coordinates interactions with and submissions to EMA. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact.
· 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.
· Act as EU regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the EU and other European countries. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
· Accountable for overall content and management of local regulatory components and filings e.g. MAA, MA variations. Contribute to overall strategy and content for local label development.
· Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
· Actively participate as member of Global Regulatory Teams supporting products.
· Responsible for EU specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.
· Leads and manages health authority meetings as applicable for specified projects.
· Manages specific projects as assigned, e.g. activities related to Regulatory Affairs Vaccines TMF Oversight.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
· BS, advanced scientific degree preferred.
· A minimum of 7 years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 7 years regulatory and/or related experience in the vaccine area.
· Vaccines and/or biologics experience is essential.
· Preferred experience in managing filings to EMA via Centralized Procedure resulting in first-time approval; or managing multiple programs in closely related development area.
· Relies on extensive experience and judgment to plan and accomplish goals.
· Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy.
· Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
· Must be strong overall and able to train/develop staff in the area of 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.
· Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership.
Job ID R0019171