At a Glance
- Tasks: Support regulatory activities and ensure compliance in a dynamic pharmaceutical environment.
- Company: Join a leading global healthcare organisation focused on innovative medicines.
- Benefits: Competitive salary, holidays, sick pay, pension, and hybrid working model.
- Other info: Exciting opportunity for growth in a supportive and collaborative team.
- Why this job: Kickstart your career in regulatory affairs and make a real impact in healthcare.
- Qualifications: Recent graduate with a passion for regulatory affairs and strong communication skills.
The predicted salary is between 30000 - 30000 £ per year.
An excellent opportunity for a talented graduate to start a career in regulatory affairs with a global healthcare organisation, our client is a market leader specialising in the development of generic and biosimilar medicines.
Job Purpose
This role supports pre- and post-approval regulatory activities to ensure compliance while meeting business needs.
Responsibilities include:
- Regulatory submissions
- Labelling and SmPC updates
- Stakeholder communication
- Audit support
- Archive maintenance
- Monitoring departmental projects in line with KPIs
Your responsibilities will include, but are not limited to:
- Preparation and submission of Marketing Authorisation variation and renewal applications
- Labelling update applications under Article 61(3)
- Change of ownership applications
- Licence cancellations
- Creation, assessment and approval of labelling artwork texts and mock-ups
- Reviewing and updating Summaries of Product Characteristics
Regulatory Affairs Associate (Graduate) employer: Carbon 60
At Carbon 60, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to thrive. Located in Harlow, this hybrid role offers flexibility and the chance to engage with a dedicated Quality team, ensuring your contributions directly impact our commitment to quality excellence. With opportunities for professional growth and development, joining us means being part of a forward-thinking company that values your expertise and dedication.
