Regulatory Affairs Executive

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Job Description

Takeda is committed to fostering a diverse and inclusive workplace, valuing the unique backgrounds and perspectives of our employees. We proudly support our Takeda Resource Groups (TRG), employee-led networks promoting dialogue and professional growth. We encourage all candidates, regardless of background, to apply and explore opportunities to contribute to and benefit from our TRGs and inclusive initiatives. We are dedicated to providing accommodations and support during the recruitment process.

For Takeda UK and Ireland, we are looking for a Regulatory Affairs Executive who will be responsible for providing technical and administrative regulatory support for the company's product portfolio in the UK and Ireland.

Key duties include maintaining and obtaining marketing authorizations, ensuring compliance with national and EU drug laws, collaborating with local and global teams, and keeping up to date with regulatory legislation and guidelines.

KEY RESPONSIBILITIES

Following direction from manager, to provide support across the RA team with the following activities:  

• Regulatory Applications: Prepare, compile, and submit regulatory applications for UK/IE, including managing fee requests, preparing submission documentation, and liaising with publishing.

• Post-Submission Actions: Update electronic systems, notify commercial teams, and respond to regulatory commitments or requests.

• Regulatory Approvals Management: Implement product information changes, manage approved mock-ups, and notify relevant parties of approvals.

• Regulatory Contact Point: Interact with local and global teams, manage direct interactions with regulatory authorities, and provide regulatory advice.

• Other Duties: Support tender requests, HTA submissions, shortage notifications, unlicensed medicines requests, and review and update SOPs.

EDUCATION, EXPERIENCE AND SKILLS

Required

• BSc in a scientific discipline.

• Minimum of 3 years in the pharmaceutical industry, experience with UK or Ireland Regulatory Authorities, preparing and submitting regulatory applications, and writing clear product information documents.

• Ability to handle multiple tasks, excellent organizational and time management skills, computer literacy, effective communication, problem-solving, and attention to detail.

Desired

• Ability to assess risks, desire to develop within the role, and interest in networking to raise the profile of the regulatory function/Takeda.

• Enthusiastic, confident and proactive. Shows initiative and a sense of urgency.

• Can do attitude

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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