Register Your Interest - International Chemistry, Manufacturing and Controls Placement

Register Your Interest - International Chemistry, Manufacturing and Controls Placement

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

In Regulatory CMC (Chemistry, Manufacturing and Controls) our experts maintain the scientific and technical aspects of products that ensure patients receive medicines that are manufactured and tested to a high quality and within compliance of the requirements of the world’s Health Authorities.

International Regulatory Affairs CMC is a key component of our company’s strategy to build regional CMC regulatory knowledge and effective local relationships with country offices to deliver appropriate regulatory strategies and deliver right first-time regulatory submissions. As part of the EMEA team you will be one of the regional experts for CMC in Europe, Middle East and Africa.

We are a global biopharmaceutical leader committed to enhancing the lives of individuals through a diverse portfolio of prescription medicines, oncology treatments, life-saving vaccines, and animal health products. Our unwavering dedication to delivering innovative solutions is the driving force behind everything we do. With a team of over 70,000 employees spread across 140+ countries, we offer state-of-the-art laboratories and inspiring offices designed to foster growth and development in our team members.

Duties

The Associate Scientist Regulatory CMC will be involved in and responsible for the execution and management of the EMEA region submissions including new product registrations and life-cycle submissions to keep our products compliant and available for patients.

In this role you will be working to:

• Generate regulatory strategies
• Assess changes to dossiers in the EMEA region
• Liaise with colleagues globally
• Review submission packages
• Work alongside our team in health authority interactions

Additionally, you will:

• Work alongside our team to deliver on operational excellence projects
• Work alongside our team in developing best practises for regulatory science
• Learn and apply regulatory policy
• Work alongside our team in health authority engagements

Eligibility/Education

• You will be looking to complete a 12-month placement in your third or penultimate year of study, returning to your course at the end of the placement
• Working towards a BSc in a scientific discipline such as chemistry, biological sciences, engineering, or a related field. Fields of study include (but are not limited to) Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry (or equivalent qualification)

Requirement: skill. Competencies and behaviours

• Operates with a high level of integrity, transparency and accountability
• Comprehends and aligns with our organization’s core values
• Aligns and fosters a culture of diversity and inclusivity
• Demonstrates initiative, proactivity and academic curiosity
• Encourages and boosts their colleagues through teamwork
• Demonstrates clear and effective communication
• Demonstrates a desire to learn and improve their performance through feedback
• Ability to work both independently and collaboratively in a team structure