Manager, Clinical Trial Regulatory Lead
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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?
Objective / Purpose:
Develops the operational implementation plan for clinical trial applications (CTAs) in EUCAN and GEM regions from initial submission throughout lifecycle, in alignment with the global submission strategy. This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products and neuroscience.
Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes in conformity with legal requirements and with Takeda’s global and regional internal procedures.
Ensures oversight and tracking of CTA activities and eTMF updates performed by the CRO Regulatory Lead. Works in collaboration with CRO to ensure compliance.
Accountabilities:
Demonstrates Takeda leadership behaviors.
Collaborates with Takeda Global and Regional counterparts, as applicable to manage all aspects of assigned CTA regulatory activities throughout the development lifecycle.
May present regional CTA regulatory strategies to leadership/senior management
Identifies regional/national requirements to support submissions of CTAs to Regulatory Authorities.
Coordinates submission preparations process and creation of administrative documents to support initial CTAs and/or maintenance submissions (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate.
Develops and maintains standardized communication/tracking/planning tools and templates for internal use.
Ensures accurate and timely submissions and communication of key regulatory milestones throughout clinical trial lifecycle (e.g., submission and approval of initial CTA, amendment/modification, HA questions/responses etc.).
Provides regulatory oversight of CRO activities as applicable to ensure that all submissions activities are tracked, and appropriate systems are maintained in a compliant manner (e.g., eTMF).
Supports non routine submission activities and deviation follow-up as needed (e.g., provision of Serious Breach submissions, submission of inspection reports, ad-hoc unexpected filings etc.).
Upon request, provides ad-hoc guidance to teams related to latest submission requirements and experiences for clinical trials.
Works as part of team to provide proactive solutions to problems arising during the CTA processes in conjunction with senior team member and/or Global/EU Regulatory Lead, as applicable.
Supports the maintenance of appropriate internal knowledge base on emerging information and trends with regulators for clinical trials.
Participates, as appropriate, and authors/reviews internal procedures and processes.
Education & Competencies (Technical and Behavioral):
BSc. Advanced scientific related degree preferred; BA accepted based on experience.
A minimum of 4 years of experience in drug regulatory affairs preferably within the EU/GEM region.
Experience with EU CTR will be advantageous.
Solid regulatory experience, including knowledge of CTA regulations and guidance governing drugs and biologics in all phases of development for [Emerging markets and/or EUCAN Markets (relevant to role)].
Has basic regulatory procedure knowledge with major health authorities in the region.
Analyzes issues with attention to detail and makes reasoned recommendations.
Promotes an inclusive culture and expresses empathy for others.
Is able to carry out assigned activities within reasonable time.
Adapts to changing circumstances and is able to build and maintain relationships.
Receives and gives feedback; expresses ideas, questions, and disagreement.
Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
Fluency in English.
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
