Regulatory Affairs Associate Scientist Industrial Placement 2021
We offer exciting 12-month placement opportunities to students that are looking to work with us to deliver on our mission to save and improve lives. A placement with us will give you the opportunity to collaborate alongside subject matter experts, bring your own ideas and share real responsibility whilst delivering on meaningful projects alongside a passionate, diverse and inclusive workforce.
This role will be based in our brand new, state-of-the-art co-working facilities in Moorgate, London; with fantastic amenities and support services including a gym, coffee bar and conference rooms.
Who we are
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With over 70,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of over 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
We are officially certified by the Top Employer Institute and been awarded the exclusive Top Employer United Kingdom Certification for the third year running.
Job Description
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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.
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
Technical Specifications
- 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)
- Fluency in an additional language is a plus
- Demonstrates numerical and analytical skills
Qualities we look for
- 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
How to apply
- Please complete the online application form and attach an editable CV and cover letter (not a PDF, please submit the CV and cover letter as 1 document).
- In your cover letter we would encourage you to answer the following questions; Why are you applying to us and why are you applying for this role? Additionally, you may include any additional information you feel further supports your application.
- Maximum word count for your cover letter: 300 – 400 words. Please do not exceed this.
- Our recruitment process for this role is: An online application, an online assessment, a telephone interview and then a final virtual assessment.