Regulatory Affairs Acquisitions Officer

We are looking for а Regulatory Affairs Acquisitions Officer to join Alvogen’s Regulatory Affairs team.
Location: Sofia

Responsibilities and duties:

- Integrate information about new acquisitions projects and disseminate correspondingly within the organization to all the relevant parties, including Corporate teams and local RA teams
- Perform due diligence on documents from suppliers, keeping in mind the of each project; understand the dossier structure and perform an overview on information available/to be asked from supplier
- If requested, perform an assessment on mandatory RA points to be included in the Agreement to be signed with the third party
- Communicate with all teams and the third party, in order that all key RA items are clarified before providing the confirmation on RA acceptability of the project. This will be assessed in line with the in force European regulations and /or local pharmaceutical laws depending on the submission type and market
- Devise a Regulatory strategy for each project, in line with all applicable requirements, and priorities set within organization; assign due dates for main RA actions (e.g. MA transfers, initial variations to be submitted, etc.)
- Communicate with third parties and local RA teams to expedite submissions and ensure regulatory compliance, in line with the RA strategy in place for a project. Regularly follow-up on status of each RA action, until project is completely migrated to the Maintenance team.
- Provide input and advice for local regulatory teams and cross functional teams on relevant regulatory aspects in relation to the Acquisitions projects. Inform relevant Departments about any RA action performed in connection to a project, which could impact other processes (e.g. delay in variation approval could have an impact for Supply team)
- Ensure that accurate and complete information is timely provided to other departments/third parties, including by preparing weekly summaries and participating in teleconferences where RA support is required
- Inform the relevant functions on the status and progress of assigned projects to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur
- Maintain the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions
- Ensure that the internal regulatory database, applicable trackers and SharePoint locations are kept up-to-date

Qualifications and Experience:
- Ideally, 2 years Regulatory Affairs experience
- Ability to work effectively without direct supervision and report succinctly and efficiently
- English language: advanced level, both speaking and writing; good understanding of English medical terms
- Computer skills: very good knowledge of MS Office tools

Job profile:
- Entry-level in regulatory affairs and pharmaceutical industry
- Chemist/ Biologist/Biochemist/Pharmacist

If interested, apply via -