Regulatory Affairs Officer

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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 we are looking for a Regulatory Affairs Officer 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 providing administrative support to the regulatory affairs team, acting as subject matter expert (SME) for key regulatory systems, maintaining marketing authorizations for established brands, collaborating with local and global teams and keeping up to date with regulatory legislation and guidelines.

KEY RESPONSIBILITIES

• Administrative Support: Provide administrative support to the regulatory affairs team including tracking project timelines, maintaining regulatory databases, executing key regulatory processes and performing critical activities within the regulatory systems.

• Regulatory Applications: Compile, and submit regulatory applications for UK/IE, including managing fee requests, assisting in documentation preparation requesting updated artwork mock-ups and liaising with publishing.

• Post-Submission Actions: Update electronic systems, notify relevant stakeholders, respond to requests and update local trackers.

• Regulatory Approvals Management: Implement product information changes within internal and external systems, manage approved mock-ups, record regulatory commitments, update local trackers and notify relevant stakeholders of approvals.

• Regulatory Contact Point: Interact with local and global teams in assigned SME area and manage direct interactions with regulatory authorities as required.

• Other Duties: Support tender requests, prepare and submit shortage notifications, manage unlicensed medicines and parallel import requests, coordinate quarterly reviews e.g. PSMF reviews.

EDUCATION, EXPERIENCE AND SKILLS

Required

• Minimum of 1 year in the pharmaceutical industry, experience with UK or Ireland Regulatory Authorities preferred

• Ability to handle multiple tasks, excellent organizational and time management skills

• Computer literacy

• Effective communication and excellent attention to detail.

• Strong problem-solving skills and ability to make decisions within own remit.

• Very competent with using electronic systems and databases.

• Team player who is self-motivated and able to prioritise and focus under pressure

• Comfortable with change and change management processes.

• Innovative and able to propose solutions to challenges.

Desired

• BSc in a scientific discipline

• 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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