Coordinator Regulatory Affairs CMC Biosimilars

Employer
Hobson Prior
Location
Nyon, Switzerland
Salary
£62466.75 - £79124.55 per annum
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Permanent
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Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Coordinator Regulatory Affairs CMC Biosimilars to join them on a permanent basis in Nyon, Switzerland.

Job Responsibilities:

  • You will assist and coordinate the CMC regulatory activities and CMC submission of Biosimilar dossiers and submissions that best serve the biosimilars business needs.
  • Initiate reviews of regulatory documents and organize consolidation meetings
  • Act as timekeeper in the preparation of Biosimilar submissions.
  • Manage, plan and organize any activity related to biosimilar CMC submissions, in coordination with other functions.
  • Act as a safeguard in the completion of the relevant CMC documentation to allow timely submissions for the assigned products/countries.
  • Act as an interface between Regulatory Affairs CMC team and other internal and external functions as appropriate.
  • Coordinate activities between different stakeholders (internal & external) for the assigned projects.
  • Formatting CMC dossier sections in line with the company's style guide
  • Independently screen comments and prepare reviewed sections for consolidation.
  • In charge of documentation management for the Regulatory Affairs CMC team.
  • Any other assigned tasks.

Key Skills:

  • Excellent organizational and planning skills.
  • Excellent multi tasking skills.
  • Strong interpersonal skills.
  • Excellent spoken and written English (a second major language would be an advantage).

Requirements:

  • Degree in a Life Science or related discipline.
  • A minimum of 3+ years in a project management role.
  • Experience in highly regulated environment (i.e. pharmaceutical, medical device).
  • Experience in preparation and coordination of regulatory submissions is a admirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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