The candidate will work in a Greek pharmaceutical company with 50 years of experience. The company manufactures both sterile and non-sterile products and is focused on exports worldwide.

Duties and responsibilities include but are not limited to:

• 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
• Contribute strategically to the development of and to the definition of the CMC content requirements for timely approval of regulatory filings throughout the product life cycle
• 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
• Work collaboratively with different departments to interpret and summarize complex data into CMC documents intended for submissions to Global Health Authorities using templates and style guide.

Qualifications:

• BS in scientific or technical discipline
• At least 2+ years of pharmaceutical regulatory experience
• Experience preparing CMC sections and supportive amendments and supplements (ICH Modules 2 and/or 3)
• 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 challenging European environment with constant upgrade and competitive salary depending on candidate’s qualifications.

Private security coverage is provided.