Regulatory Affairs Manager

A speciality biopharmaceutical company is currently recruiting a Regulatory Affairs Manager to join their office in Zurich. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.

Job Responsibilities:

• Acting as regulatory representative in biologics/biosimilars project life cycle development teams.
• Interacting with project management, clinical development and operations, business development, regulatory operations, manufacturing, quality control, and analytical development.
• Contributing proactively towards regulatory strategy development and execution.
• Contributing towards biopharmaceutical dossier preparation.
• Participating in HA meetings and preparation of responses to Health Authority questions (US, EU, global).
• Collaborating with Regulatory Operation for the management of regulatory database (IDMP).

Skills and Requirements:

• Master's degree in science (pharmacy, biology, chemistry).
• 3 - 5 years biopharmaceutical industry experience is a must.
• Knowledge of EU and US regulatory landscape is a must and global regulatory landscape is desirable.
• Regulatory authoring experience.
• Proven experience in cross-functional set up.
• Manufacturing and QA/QC experience is desirable.
• Any additional regulatory qualifications are desirable.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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