Regulatory Affairs Post-approval Senior Officer at Demo S.A.

Athens, Attica, Greece -

Full Time

Start Date

Immediate

Expiry Date

04 Jun, 26

Salary

0.0

Posted On

06 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Regulatory Documentation, Regulatory Projects, Regulatory Maintenance, Regulatory Variations, Renewal Procedures, Scientific Responses, Regulatory Authorities Liaison, Local Agents Liaison, Distributors Liaison, Pharmaceutical Dossier Submission, Product Registration Support, CMC Variation Filling, English Fluency, MS Office, eCTD Software

Industry

Pharmaceutical Manufacturing

Description

At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Post-approval Senior Officer (Non-EU markets) to join our team. This position is based in Athens, Kryoneri. Responsibilities: Understanding of Regulatory strategy and documentation requirements in Non-EU markets ( Middle East, Africa, Asia, CIS, LATAM). Act as responsible Regulatory Team member for assigned regulatory projects. Assist and support the junior personnel of the team for the projects they have undertaken. Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures). Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities. Liaise with international regulatory authorities, local agents, and distributors. Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary. Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products Preparation of submissions including CMC variation filling. BSc Degree in Chemistry, Biology or relevant field. 2-4 years demonstrated experience managing regulatory submissions in Non- EU markets ( Middle East, Africa, Asia, CIS, LATAM) Fluent in English and good MS Office skills Good command of eCTD software and CESP platform. Strong organization skills, multi-tasking and able to meet deadlines Effective communication and relationship management Knowledge of EU and global regulatory guidelines Ability to work under pressure, resilience The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

Responsibilities

The Senior Officer will manage regulatory projects for assigned Non-EU markets, supporting junior personnel while collecting, preparing, and compiling regulatory documentation for product lifecycle maintenance, variations, and renewals. This role involves compiling scientific responses to regulatory deficiencies and liaising with international authorities, agents, and distributors.