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Global RA CMC Strategy - Munich Area

Employer
i-Pharm Consulting
Location
Munich, Bayern, Germany
Salary
Negotiable
Start date
1 Feb 2021
Closing date
15 Feb 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

My client is an international growing company. In the third quarter of the last year the business got a net income of 30 USD Millions, especially thank to the research work of his 4 laboratories.

For the 2021, the company is aiming an even higher level, therefore the team wants to expand with a new Global CMC Regulatory Affairs Manager, who is keen to work on new drugs and to take over strategical tasks within Pre-Approval Registration Projects.

Your key function is namely the development of a solid, business-sounded global CMC RA Strategy, so that you will frequently act as the In-House advisor for your colleagues from Clinical, R&D as well as for the QA.

As Global CMC Registration Manager, you will daily prove your scientific and regulatory skills at different challenges - Your agenda is really varied and exciting!

On the other hand, you will also be in charge for representing the global CMC regulatory strategy at global teams, at which several international stakeholders take part. You will therefore also develop your social skills, so that your core function will take some distance from the classical life cycle, to bring you closer to the business strategy.

Creativity and business acumen are your daily bread and butter: You will have fun at your job even after years after your first day there!

Your core tasks:

  • Applying your scientific and Regulatory Intelligence skills for developing a solid global CMC RA Strategy
  • Being the point of contact for the relevant Health Authorities
  • Taking part to implementation meetings for international registration processes
  • Acting as In-House Advisor for your colleagues from Clinical and R&D for ensuring a smooth registration process
  • Interacting with several stakeholders on global level to ensure a correct dossier composition and an efficient work-flow
  • Taking part to the composition of the relevant IMPD Dossiers for international submissions and scientific briefings with global Health Authorities
  • Supporting the Post-Approval tasks

Location: Munich area

Starting Datum: ASAP according to your notice period

Contract Type: Permanent. You will be hired directly from my client

Salary: Negotiable according to your experience and qualifications

Your Profile:

  • Solid experience as CMC Regulatory Affairs Manager
  • You have already worked on drug in development
  • High command of English language, written and spoken
  • Ability to work in EU countries without needing any sponsorship or visa from the new employer

Happy to recommend someone? If you want to recommend someone, and we manage to place your referral, you will get a small 'thank you' gift from us!

My Contact Details:

I-Pharm Consulting

Dr Emma Fleury, Practice Manager für Recruitment in Regulatory Affairs

efleury@i-pharmconsulting.com

TEL: +49 89 3803 5861

Due to the high number of applications we could be not able to come back to you, if your requirements are too distant from the one requested above. We thank you in advance for your understanding

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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