Regulatory Affairs Associate (Graduate)
Bracknell, England, United Kingdom (Hybrid) · Temporary
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- Experience
- Any
- Salary
- GBP 30,000 – GBP 30,000 / year
- Openings
- 1
- Posted
- 5 days ago
- Work mode
- Hybrid
- Education
- BSc Life Sciences
- Eligibility
- Applicants must be within commutable distance to Bracknell and eligible to work in the United Kingdom. A minimum of 12 office days per month is required to facilitate effective team collaboration and learning.
- Resume
- Required to apply
Where you'll work
Job description
Overview
This opportunity offers a twelve-month fixed term contract for an aspiring graduate to begin a career in regulatory affairs with a leading global healthcare company specialising in generic and biosimilar medicines. The role is based in Bracknell, UK and combines both onsite and remote elements.
Work Hours and Location
The position requires 37.5 hours per week, Monday through Friday, with a hybrid work model demanding at least three days onsite weekly in Bracknell.
Job Responsibilities
- Prepare and submit regulatory documents including marketing authorisation variations, renewals, labelling updates under Article 61(3), change of ownership notifications, licence cancellations, and more.
- Develop, evaluate, and approve labelling artworks and product characteristic summaries.
- Communicate regulatory approvals clearly to internal and external stakeholders.
- Support and track departmental projects aligned with key performance indicators.
- Follow global and local standard operating procedures (SOPs) and working instructions rigorously.
- Maintain regulatory archives accurately.
- Assist with regulatory support during internal and external audits.
- Perform other duties that enhance the Regulatory Affairs Department's effectiveness.
Candidate Requirements
- Recent graduate within two years holding a BSc in Life Sciences from a UK university.
- Ability to manage multiple deadlines flexibly in a fast-paced setting.
- Previous regulatory affairs experience in generic or pharmaceutical sectors is preferred.
- Understanding of regulatory maintenance processes and adaptability to change.
- Strong time management, prioritisation, attention to detail, and teamwork skills supported by academic or work achievements.
- Excellent interpersonal skills to form effective working relationships, comfortable collaborating across various levels.
- High proficiency in Microsoft Office (Outlook, Excel, PowerPoint, Word).
- Fluent English communication skills, both written and spoken.
Benefits
- Collaborative team environment.
- Engagement with innovative scientific developments.
- Interaction with diverse teams and people.
- Opportunities for professional growth.
- Contributing positively to patient outcomes.
Additional Information
Candidates should reside within commuting distance of Bracknell and be prepared to attend the office at least 12 days monthly to facilitate learning through team interaction. Eligibility to work in the UK is mandatory.
Compensation
The salary is £30,000 per annum, in addition to holiday entitlement, sick pay, and pension benefits.