Senior Regulatory Affairs Officer
A fantastic opportunity to join a fast-growing organisation with an exciting portfolio pipeline.
Role and Responsibilities:
* Manage marketing authorization dossiers and submissions (MAAs, lifecycle activities, variations, MA transfer etc.) for a portfolio of pharmaceutical products.
* Promote and lead by example high-quality regulatory best practices, process efficiencies, effective communication, planning, and delivery of GPA and Corporate projects.
* Act as a reference and contact person for the product and countries under your responsibility. Maintain a roadmap and product status for your countries.
* Ensure good communication flow with affiliates, partners, and other departments as relevant.
* Prepare the regulatory strategy for registration of medicinal products and variations in region/country of responsibility in collaboration with local contacts as relevant.
* Prepare and file submissions including life-cycle maintenance variations, initial MAA fillings, labelling updates, renewals, and marketing authorisation transfers.
* Act as a mentor and/or contact person for students and junior or external team members as relevant.
* Promote best regulatory practice and approach in business operations.
Person Profile:
* Scientific, pharmaceutical, or Regulatory Affairs degree.
* Three+ years and proven track record of successful Regulatory Affairs experience.
* Experience in EU and non-EU international markets.
* Good knowledge of CTD Module 1 to 5 dossiers and requirements for different types of submissions.
* Strategic mindset for submission planning and local labelling opportunities.