Munich - CMC Reg Affairs Consultant - ATMP / Small Molecules

1 week ago

City of London, United Kingdom NonStop Consulting Full time

Non Stop Consulting have partnered with a rapidly expanding consulting company in south Germany who are seeking several candidates to join their team. This is a mid-sized company who promote a social, positive working atmosphere. They are well known in the industry to treat their staff very well, with less than 4% staff turnover since opening their business. This means you will benefit from stable, long term employment without needed to switch companies For this role, we are seeking candidates highly experienced (10-15 years) in conducting clinical trials with a strong focus on regulatory affairs. This role gives you the opportunity to use your experience and give expert advice on trials across Europe, US and even China.

There is a very high degree of flexibility in this role, you can choose your projects, which allows you to focus only on projects you are passionate about and achieve a healthy work/life balance. It also gives you the security and social environment from a permanent role while also a high degree of independence, making it a great option for freelance workers.

This position will give you the opportunity to be the quality expert and give advice on drug substances and products, from pre-clinical development to approved products. Representatives from pharma/biotech/CRO's will come to your office and you will guide them on CMC, quality , documentation and strategies for their processes/ We are seeking highly experienced candidates with a minimum of 10 years industry experience in quality within a pharmaceutical / CRO environment

Key Responsibilities:

Provide expert advice to clients in the areas of regulatory affairs for drug development and regulatory requirements
Ensure CMC packages and documentations meet regulatory requirements and will meet approval for submission
Prepare MAA and BLA/NDA as well as for IMPD and IND
Monitor gap analysis of client packages, identifying development and strategy issues
Prepare and conduct agency/client meetings
Advice on operational and strategic aspects for companys
Management of operational and strategical aspects with CDMOs
Monitor changes regulations requirementsRequirements:

PhD in Life Science field (Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology)
Minimum 10 years experience in pharmaceutical regulatory affairs in a CMC focused role
ATMP or Small Molecules experience is a must
Experience with regulatory filings
Fluent English - German an advantage
Willing to relocate to MunichBenefits:

Base salary + paid per hours consulting
Professional, friendly working environment

If the above aligns with your skills and experiences, the responsible recruiter Billy O'Brien would love to hear from you. If it doesn't quite match, but you're open to working in the Regulatory Affairs environment, please don't hesitate to get in touch with Billy as NonStop Consulting works with a variety of clients. New roles are opened by the day, so we can begin to start searching for a role that's perfect to you

Please send your application via email to: b.obrien@nonstop-recruitment .com

Find Billy on LinkedIn at: https://(url removed)/in/billy-o-brien-(phone number removed)a

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