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Regulatory Affairs CMC Director

Employer
NonStop Consulting
Location
Hellerup
Salary
€120000 - €150000 per annum + + Pension + Bonus + Warrents
Closing date
Dec 13, 2019

View more

Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

Regulatory Affairs CMC Director

Location: Hellerup, Denmark (Need to be on site)
Hiring date: ASAP
Type: Permanent

*Open for all international candidates, who fill the requirements*

Information about the role

This is a one time opportunity to be a part of an upcoming biopharmaceutical company, with an exiting platform and several drugs in the pipeline. My client is about to file their first NDA in Q1 2020, and will be in a need of a heavy CMC profile, to be a leading part of the CMC team.

It is important that you have experience writing and reviewing CMC sections of NDA, CTA, IND or similar, as there will be a lot of these submissions, and we need someone to keep cool and know how to accomplish challenges in hectic times.

You will be working within their therapeutically areas which is endocrinology and oncology.

Your profile:

  • At least 5 years of experience managing a team
  • 10+ years of experience in a regulatory CMC position in the pharmaceutical industry
  • Experience with IND/CTA, NDA/BLA/MAA and life cycle management
  • Experience with external stakeholder management and interaction with authorities

It is a once in a lifetime opportunity to be a leading part of a growth adventure with one of the most exiting upcoming Danish pharmaceutical companies - setting the structure and function of Regulatory Affairs. As Director Regulatory Affairs (CMC), you will be part of the teams driving my client's development projects further.

You will have 4 direct reports from the CMC team and they all have 15 years of experience in a CMC position, which is why you need in-depth knowledge to lead and coach the team.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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