Regulatory Affairs Associate with German

We are looking for a Regulatory Affairs Associate with German language skills. As the RA Associate you will be technically competent and continually developing the skills as defined in the key accountabilities section of this document. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. The guidance of more senior staff may be needed to accomplish more complex tasks.

Key Responsibilities:

Preparation & submissions of regulatory files

Communicate with Regulatory Operations on the planning of marketing applications and post-approval supplements and variations

Coordinate the review and approval of submission-ready documents

Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations

Skills and Experienced required for the role:

University degree in a scientific or technical discipline

Experience with CTA Submissions on German markets - nice to have

Thorough understanding of regulatory requirements

Excellent project management skills

Client-focused approach to work, teamwork and collaboration skills, excellent interpersonal and intercultural communication skills, critical thinking and problem-solving skills

Fluent English written and spoken and at least intermediate German language skills

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