REGULATORY AFFAIRS SPECIALIST

Profile

Bachelor’s degree in Chemistry or Health Sciences

Very good English skills.

Good communication skills.

Strong computer skills, including MS Office applications.

Additional experience and knowledge in Organic Synthesis or analytical chemistry will be valued.

Methodical, organized, proactive and results-oriented person is needed. Teamwork. 

Ability to organize own work, prioritize different assignments, and work under pressure.

Respect established timelines, expectations, priorities, and objectives.

Functions

DMF´s preparation.

Submissions of DMF´s in the Regulatory Agencies (FDA, EDQM….).

Maintenance and updating of the DMF’s registered in the Regulatory Agencies.

Reply to the deficiencies received from the Regulatory Agencies.

Ability to establish and maintain effective working relationships with clients; discuss regulatory issues and defense meetings.

Participation in the management of new projects with clients.

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