Expiry Date: 10-12-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Associate DIrector Regulatory Affairs CMC, Biosimilars, Zug/Zurich
This is a permanent role at an Associate Director grade, Global Regulatory Affairs CMC.
About the Client
They are a global research bio-/pharmaceutical organization, with a good count of marketed products and a focus on the space of neurology to deliver new drugs in order to address neurological diseases.
The company vision underpins the ambition to transform lives of the people with severe diseases for good and the focus is always the patients. They are continually working to advance and get new expertise to fulfill this objective and they now intend to expand the portfolio by bringing in their preclinical assets into the clinical phases.
About the role:
As the Global Regulatory CMC Lead, the responsibility of the development and delivery of regulatory CMC strategies will be your focus on, to innovate product development, initial approval and subsequent LCM activities for your assigned projects. After developing your GRP, the execution of the plan and the accounting of the requirements of the Health Authorities in different territories (US, EU, Japan and China) will be driven by you and supported by your regulatory team members.
With that being said, the major accountabilities that you will have on this role are to direct and supervise the regulatory CMC strategies in development as well as the life-cycle management of assigned products. With your guidance, collaboration and strategy, you will help to assess risks with product development, set the direction of the global regulatory submission process and assess the impact of proposed CMC changes to licenses or CTA’s or ongoing programs.
Experience and Skills:
My client is looking for an individual with a BS Degree in pharmacy, chemistry, biology or pharmacology with a minimum of 6 years of experience in the pharma/biotechnology industry with regulatory affairs and technical management experience.
Experience in regulatory CMC late stage development leading a submission (NDA, BLA, and MAA), interfacing with regulatory authorities in EU and US and knowing regulatory pathways for Biosimilars and filing will be an advantage.
As well, the soft skills set that the client is looking for should have the ability to lead and influence project teams and committees to deliver group goals and demonstrate your leadership and communication skills. Strong sensitivity, interpersonal skills and how to deal effectively with senior staff including medical, scientific and manufacturing personnel is mandatory as well as supervise, guide, train and prioritize workload of direct reports.
Package & Benefits
This role is based in the Zug/Zurich area or Switzerland and comes with full relocation to Switzerland from anywhere in Europe (UK excluded), a very competitive salary + bonus with personal and company multipliers and stock plan that will grow with you every year. There is ample opportunity to grow in this organization and you will be impacting directly on the strategy and the development of the company.
Note: My client has committed to do Digital Hiring and Digital On-Boarding process in place to allow a smooth transition during the outbreak. At this point, if you are not residing in Switzerland the role will require you to relocate, which is fully paid for by my client.
To apply for this role, please contact Oli Dimitrov on +44 207 801 3388 or Matt Greig on +44 207 801 3386. Alternatively, please send a full CV to email@example.com or follow the registration process on the site and we will reply by return.
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