Munich – CMC Reg Affairs Consultant – ATMP / Small Molecules

Job title:

Munich – CMC Reg Affairs Marketing consultant – ATMP / Small Molecules

Firm

NonStop Consulting

Job description

Non Cease Consulting have partnered with a quickly increasing consulting firm in south Germany who’re searching for a number of candidates to affix their workforce. It is a mid-sized firm who promote a social, optimistic working environment. They’re well-known within the business to deal with their employees very nicely, with lower than 4% employees turnover since opening their enterprise. This implies you’ll profit from steady, long run employment with out wanted to change corporations For this position, we’re searching for candidates extremely skilled (10-15 years) in conducting medical trials with a powerful give attention to regulatory affairs. This position offers you the chance to make use of your expertise and provides knowledgeable recommendation on trials throughout Europe, US and even China.There’s a very excessive diploma of flexibility on this position, you may select your initiatives, which lets you focus solely on initiatives you might be obsessed with and obtain a wholesome work/life steadiness. It additionally offers you the safety and social surroundings from a everlasting position whereas additionally a excessive diploma of independence, making it a fantastic choice for freelance employees.This place will provide you with the chance to be the standard knowledgeable and provides recommendation on drug substances and merchandise, from pre-clinical improvement to permitted merchandise. Representatives from pharma/biotech/CRO’s will come to your workplace and you’ll information them on CMC, high quality , documentation and methods for his or her processes/ We’re searching for extremely skilled candidates with a minimal of 10 years business expertise in high quality inside a pharmaceutical / CRO surroundingsKey Duties:

• Present knowledgeable recommendation to shoppers within the areas of regulatory affairs for drug improvement and regulatory necessities
• Guarantee CMC packages and documentations meet regulatory necessities and can meet approval for submission
• Put together MAA and BLA/NDA in addition to for IMPD and IND
• Monitor hole evaluation of shopper packages, figuring out improvement and technique points
• Put together and conduct company/shopper conferences
• Recommendation on operational and strategic elements for companys
• Administration of operational and strategical elements with CDMOs
• Monitor adjustments laws necessities

Necessities:

• PhD in Life Science discipline (Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology)
• Minimal 10 years expertise in pharmaceutical regulatory affairs in a CMC centered position
• ATMP or Small Molecules expertise is a should
• Expertise with regulatory filings
• Fluent English – German a bonus
• Keen to relocate to Munich

Advantages:

• Base wage + paid per hours consulting
• Skilled, pleasant working surroundings

If the above aligns along with your abilities and experiences, the accountable recruiter Billy O’Brien would love to listen to from you. If it does not fairly match, however you are open to working within the Regulatory Affairs surroundings, please do not hesitate to get in contact with Billy as NonStop Consulting works with a wide range of shoppers. New roles are opened by the day, so we will start to start out trying to find a job that is good to you!Please ship your utility through electronic mail to: b.obrien@nonstop-recruitment .comDiscover Billy on LinkedIn at: https://www.linkedin.com/in/billy-o-brien-07317123a/

Anticipated wage

€100000 – 150000 per 12 months

Location

Central London

Job date

Fri, 29 Mar 2024 23:15:49 GMT

To assist us observe our recruitment effort, please point out in your electronic mail/cowl letter the place (globalvacancies.org) you noticed this job posting.