Regulatory Affairs Officer

LMW is seeking a dynamic and experienced Regulatory Affairs Officer on behalf of a Greek pharmaceutical company located in Polydendri, Athens.

As Regulatory Affairs Officer, you will ensure that company is executing regulatory strategies and supporting interactions with regulatory authorities appropriately, especially in third countries.

Responsibilities

• Develop and lead the execution of submission plans. Consult on and be accountable for the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects
• Contribute to the evaluation of the impact of changes to the regulatory landscape
• Ensure that company policies and procedures are in compliance with regulatory requirements
• Maintain documentation related to regulatory affairs
• Review product promotional materials for compliance with regulations
• Plan and manage resource needs for authoring, review and approval of submission-ready documents for a project
• Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
• Review submission documents to ensure messaging and content is clear and consistent within and across documents
• Stay up-to-date with changes in regulatory legislation and guidelines

• BSc in Pharmacy, Chemistry, Biology or relevant field. Higher degree in one of these fields or Regulatory Affairs is preferred.
• At least 2+ years of pharmaceutical regulatory experience
• Strong understanding of regulatory affairs legislation and guidelines
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Ability to balance regulatory objectives with business objectives
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
• Resourceful, creative, enthusiastic, and results-oriented
• Strong interpersonal skills and the ability to effectively work with other departments and clients

• The company offers a competitive remuneration package along with a clear vision to establish a strong presence in a fast-growing, pharmaceutical environment.