RAF MANAGER! Regulations in the Big Apple!
- Employer
- NonStop Consulting
- Location
- New York
- Salary
- USD100000 - USD110000 per annum + NEGOTIABLE
- Closing date
- Jun 23, 2016
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
My client is looking for a candidate ready to take control of the Regulatory Affairs in it's headquarters located in NY ASAP. You will be working in a dynamic environment, where new products dedicated to rare diseases are constantly developed and introduced in the market, making the role even more stimulating.
The candidate will need an experience of minimum 3 years in Regulatory Affairs (within the Pharmaceutical industry) in order to cover the responsibilities and submissions all the products will require. You will work directly under the line manager, a luminar in regulations, who will be able to teach you, improving even more your knowledge.
Some of your responsibilities will be coordinating the preparation of regulatory submissions (briefing documents for meetings with Authorities, INDs, DSURs, NDAs, BLAs, Annual Reports, amendments, Variations, etc.) to ensure that "quality documents" are prepared in line with Company's strategy and plans and in compliance with the applicable regulatory requirements for both format (e.g. CTD) and content (e.g. FDA guidance, ICH, Pharmacopoeias, etc.).
Being as main contact point with regulatory authorities in US and Canada for communications relating to assigned projects/products.
Review of promotional and scientific information, according to local requirements and codes.
What we are looking for:
- 3 years experience within the Regulatory Affairs field (mandatory)
- previous experience within the Pharmaceutical company
- experience in post-marketing regulations (ANDA,eCTD,NDA,IND)
- US citizen
- proactive character
- will to grow professionally in a dynamic environment
- positive attitude
What we offer:
- competitive salary
- permanent contract
- professional growth
- responsibility and visibility
- highly qualified and specialized environment
- valuable experience within a multinational company
IF YOU ARE INTERESTED IN THE OFFER, APPLY AND SEND ME A COPY OF YOUR CV !
Simone Mantillaro,Market Researcher,NonStop Pharma
Email: s.mantillaro@nonstop-pharma.it
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.
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