Director Regulatory Affairs - Post-marketing focused
Hey you! Yes, you... Are you a (senior) manager or an associate director in regulatory affairs ready to take your career to the next step? Are you looking to become a director regulatory affairs in a role that's both hands-on and strategic?
Do you like working with Americans? If yes: come and get your dose of Freedom with a capital "F" in this brand new Director of Regulatory Affairs role in the beautiful city of Amsterdam!
"But Michael, Dutch is an ungodly and complicated language, you can't possibly expect me to speak it, let alone file submissions in it..."
Of course I can't: you only need English and a solid dose of ambition.
The (Associate) Director Regulatory Affairs Europe will direct, plan, and implement all regulatory operations for pharmaceutical products in the European Union. This will include strategies for new product registration and submission of appropriate regulatory filings.
In terms of Planning and Development: the director adds a vast knowledge of the interpretation of rulings, policies, guidelines and regulations of the EMA, and other agencies as they relate to our products and practices.
The right candidate for this role will be responsible for the following:
* Ensure all aspects of RA are planned and formulated and executed according to EMA
* Cooperate with the rest of the business team to prepare product development strategies for product labeling and promotional material in Europe. Also: Artwork creation with the global team
* Leading RA projects and teams by ensuring all activities are on target.
* Responsible for reporting ALL submissions to EU agencies with third party providers.
* Ensures timely preparation and valid submissions for business and regulatory review.
* A minimum of a MS in pharmaceutical, science or related field
* Minimum of 10+ years of pharmaceutical industry experience, and proven success in regulatory submission in the pharmaceutical or biopharmaceutical industry in Europe. FDA experience is welcomed too
* At least 10 years in Regulatory Affairs. CMC experience is an advantage
* Knowledge of GMP is an advantage
* CRO management experience is the best
* Experience or an affinity with start-ups is definitely an asset
* Knowledge of GxP
* Fluent in English
You can contact me (Michael van Hooft) at:firstname.lastname@example.org or call me at +32 (0)2 891 98 99 with extension number 3147
You can also visit our website at: www.nonstop-recruitment.com for more awesome career opportunities.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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