Job Title:
Regulatory CMC Specialist
Job Description:
We are seeking a highly motivated individual to support the management and maintenance of Marketing Authorisations in compliance with European and international regulations. In this role, you will work closely with regulatory authorities, internal stakeholders, and external partners to ensure the smooth lifecycle management of pharmaceutical products.
Key Responsibilities:
* Prepare and submit Marketing Authorisation Applications, variations, renewals, and post-authorisation activities in line with European regulatory requirements.
* Manage communications and respond to queries from regulatory authorities (EMA, EU and non-EEA competent authorities).
* Publish dossiers and submissions using validated document management systems and ensure correct electronic formats.
* Ensure compliance between authorised Marketing Authorisations and manufacturing site procedures.
* Review and evaluate proposed changes related to quality, manufacturing, supply chain, and Contract Manufacturing Organisations.
* Review and approve product artwork to ensure regulatory compliance.
* Liaise with corporate office and licensing partners to support regulatory activities.
* Manage correspondence and compliance activities with regulatory authorities.
Required Qualifications and Experience:
A bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline is required. Minimum 5 years of experience in pharmaceutical regulatory affairs, with a focus on CMC activities, is also necessary. The ideal candidate will have proven experience preparing and submitting Marketing Authorisation Applications and related documentation in the EU.
Benefits:
* Health insurance
* Performance bonus
* Pension scheme
* Parking space with EV charger
* Flex time
* Work from home scheme