• Permanent
  • Zürich, Switzerland
  • CHF180 per annum, Benefits:Performance Bonus and other advantages USD / Year

Website Headcount AG

Associate Director Regulatory Affairs CMC

headcount AG is a Zurich-based consultancy serving clients in the pharmaceutical, biotechnology, medical technology, diagnostic, OTC and chemical market segments.

Our client is a Zurich-based clinical-stage biopharmaceutical company focused on the development and manufacture of next-generation bioconjugate vaccines using an approach that is involved in a Global Race.

The company is focusing this time on the late-stage development of a Vaccine targeting very infectious Bacteria for travellers and low-income countries. 

Working closely with Manufacturing and Development you would be responsible for the full Regulatory Pathway, working on a late-stage development Vaccine, the biggest challenge is to get the process right the first time to avoid process changes and new approvals. Also responsible for Audits at CMOs, from a Regulatory perspective, you would be heavily involved in stakeholder management.  

Reporting directly to the CSO and Co-founder of the company, you would evolve in a flat hierarchy in a very dynamic and driven startup environment. 

YOUR RESPONSIBILITIES

_Establishing, leading, and driving the global CMC operational and regulatory activities for one of our vaccine products to achieve market authorization
_Selecting and managing partners for phase II/III CMC activities for both API and IMP manufacturing
_Establishing supply chain strategy for the vaccine candidate for clinical phase II/III development and market supply ensuring regulatory compliance
_Leading and driving global CMC submission activities
_Representing Global Regulatory CMC on cross-functional project teams and maintaining collaborative networks with key stakeholders
_Initiating, maintaining, and leading Health Authority interactions and negotiations, setting objectives and risk mitigation plans
_Providing strategic advice and direction within the department and cross-functionally through specialized assignments

WHO YOU ARE

_Proven track record of successfully managing CMC campaigns for biologics (phase I, II, and/or III)
_Technical experience in QbD, process and analytical validation, CMC-bridging strategies
_Substantial expertise and experience in regulatory affairs, preferably for biologics
_Positive, proactive, goal-oriented can-do attitude
_Focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
_Strong project management skills
_Excellent verbal and written communication skills in English

I am looking forward to telling you more! 

headcount AG
Megann Löffler

Dreikönigstrasse 55
8002 Zürich
megann@headcount.ch
https://headcountch.wpengine.com

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