Lifecycle Manager

We are looking for an enthusiastic Lifecycle Manager to join our dynamic Adalvo team. This position offers an opportunity to well-suited candidates to join a growing, fast paced energetic environment and culture.

SUMMARY OF POSITION

The Lifecycle Manager will play an important role in the day to day running for the Regulatory Affairs function at Adalvo, in line with the Company’s strategic goals.

ORGANIZATION STRUCTURE

This position will report to the Director of Regulatory Affairs, and will support the department, as necessary.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Initiation, coordination and tracking of variations for the assigned medicinal products, approved through European procedures (MRP, DCP, CP) or national submissions across all regions of interest

• Coordination of variations or other activities taking into consideration the impact on product launch or replenishment orders

• Coordination and tracking of renewals and MA transfers for the assigned medicinal products, approved through European procedures (MRP, DCP, CP) or national submissions across all regions of interest

• Ensuring that all the additional processes related to national submissions (DMF, PMF, GMP accreditation etc.) are maintained and renewed on time and that their submission/approval process does not affect the MA validity

• Ensuring that all responses to authorities’ requests are correct, complete and timely submitted, including the responses to LoDs for the allocated projects

• Collaboration with the Pharmacovigilance Department for safety variations submission

• Ensuring that complete and correct documentation is received, so that responses are sent to the authorities’ requests, within the deadline imposed by that specific authority/legislation in place

• Informing all involved departments on the status and progress of the assigned projects, so that objectives are met, any potential issue is identified and solutions are being found

• Documenting and tracking regulatory related processes within the organisation

• Compile, verify and publish submissions using electronic publishing software considering the submission deadlines and technical requirements on management of dossiers lifecycle

• Perform regular reviews of the information available on the internal SP

• Keeping up-to-date the database as well as relevant trackers

QUALIFICATIONS & REQUIREMENTS

- At least 7 years Regulatory Affairs experience

- EU procedures experience would be an advantage

- Ability to work effectively without direct supervision and to be able to report succinctly and efficiently

- English language: advanced level, both speaking and writing;

- Computer skills: very good knowledge of MS Office tools

- Project management capabilities, including but not limited to creation of timelines, organization of meetings, meeting minutes, planning and execution

- Solution oriented working skills