Student Placement - Associate Specialist, Regional Regulatory Operations, EU + EEMEA
About this role
Job Description
This role will be based in our modern
state-of-the-art
co-working facilities in Moorgate, London. This site, at the heart of London provides fantastic amenities, support
services
and collaborative workspaces with convenient transport links
.
Brief Description of Position
You will work within our Global Regulatory Affairs and Clinical Safety (GRACS) organisation, in the Regulatory Affairs Operations International team, which is based in Europe.
You will support the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective across the Europe, Middle East, and Africa regions (EU & EEMEA).
As a member of cross-functional team and for the assigned products, you will support the team to manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes.
This position requires a keen interest of the regulatory landscape, its registration procedures and a willingness to understand the technical requirements for dossiers.
Primary Activities include but are not limited to:
Support the planning and managing of regulatory operation projects from authorisation through delivery to country regulatory affairs teams and/or Health Authorities.
Supporting the regulatory submission plan for the assigned projects/products and maintaining the related project milestones.
Participate in cross-functional forums and meetings
With manager support, drive the submission assembly and delivery process with the Global and/or Regional Submission Publishing team to ensure timely assembly, publishing and archival of assigned products/submissions as per the agreed timelines.
Responsible for accessing and maintaining the regulatory systems and databases to fulfill daily functions.
Assist in identifying opportunities to continually improve the efficiency of the submission processes and systems and participate in small-scale process improvement projects.
Learn knowledge on the regional regulatory procedures on internal and external guidelines and standards.
Qualifications, Skills & Experience
Requirements
- Yo
- u
- must
- be
- currently
- studying
- at a
- UK
- university and will be looking to complete a 12-month student internship as part of your undergraduate degree.
- Technical Requirements are flexible, but an affinity for and capability to learn Regulatory Information Management systems to execute operational tasks will be a significant asset.
- How to Apply
- (Please Read)
- :
- Please complete the online application form by answering questions within the application and upload your CV and Cover Letter
- in a
- combined
- document in the ‘resume/CV’ section.
- Our standard
- Future T
- alent recruitment process is: An online application, a virtual conversation and then a final assessment.
- Next Steps:
- In the event of
- your successful progression to the next stage, one of our future talent team will contact you within two - three weeks of the application closing date.
- Start Date:
- June 202
- 6
- Equal Opportunity Employer:
- We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
- For more Information visit
- our
- Future Talent page!
- #UKFT25
- Required Skills:
- Preferred Skills:
- Current Employees apply
- HERE
- Current Contingent Workers apply
- HERE
- Search Firm Representatives Please Read Carefully
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. Â No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
- Employee Status:
- Intern/Co-op (Fixed Term)