A Greek pharmaceutical company, with a continued presence in the Greek and international pharmaceutical market up to the present day, is seeking for a Regulatory Affairs Senior Officer.

Joining our Organization, you will recognize that:

• Our company fosters a supportive and collaborative work environment and promotes work-life balance.
• We offer Career Development and Growth Opportunities investing in  training and development programs
• Challenging and Meaningful Work for Employees motivated by purpose-driven work
• Competitive Compensation and Benefits: Fair and competitive compensation packages, including salary, bonuses, and benefits, are essential in attracting top talent.
• Company Reputation and Stability: We are a company with a track record of success, a strong reputation,a good market position and financial stability, positive reviews from current and former employees.
• Career paths aren't predefined and you have the opportunity to grow, learn from our industry experts, and develop the way you want to.

Key responsibilities

• Compiling relevant documentation, in accordance with NTA and ICH guidelines intended for Pharmaceutical Dossier submission and product registration and support internal activities of Regulatory department in order to ensure regulatory compliance of registered and on market products.
• Update existing technical dossiers (Modules 1, 2.3, 3) of pharmaceutical products, in order to comply with current EU requirements or other country specific requirements (for non-EU registrations) to support Out-Licensing activity.
• Communication and close collaboration with all involved departments of the company and all external parties in order to collect the required data for registration of CTD dossiers and e-CTD, responses to authorities’ questions, filling variations, maintaining timelines of projects.
• Responsible for the filing in due dates and for handling correspondence with the competent authorities.
• Life cycle management of marketing authorizations, by preparing for submission of appropriate variations for post approval changes of the CTD dossiers, renewals and rest of Life cycle management activities.
• Drafting, regulatory review, and approval of labelling, assuring its compliance with the guidelines issued by the EU or the Regulatory Authorities of non-EU countries.

Requirements & Skills

• Bachelor’s Degree in Chemistry, Biology or Pharmaceutical Studies.
• 2 years’ previous experience in RA and/or RnD department.
• Knowledge of EU regulatory framework, ICH and EU requirements of GMP & GLP.
• Excellent knowledge and handling of both verbal and written English language.
• Good knowledge of MS Office suites (Word, Excel, Power Point, Outlook).
• Ability to multi-task, work both independently and in a team environment.
• Strong communicational skills.

Being a member of our Organization you will have the opportunity to grow, learn from our industry experts and achieve your career aspirations.

We are investing in the development of our team, committed to meeting the needs of our employees and their families.

Our environment is geared to fuel curiosity, encourage experimentation, and generate learning as this is the way we develop ourselves and our organization.

With competitive compensation and recognition programs and standout benefits we ensure employees feel supported both at work and home.

We provide employees with a private insurance contract for their optimal health and well-being.