Senior Regulatory Affairs Consultant with Global Focus

Search4S Dustgoat AB / Apotekarjobb / Malmö
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Do you wish to share and expand your deep understanding of regulatory strategies for drug development?

Over the last years, NDA supported over 40% of the new medicinal products that were approved in the EU. We are now expanding our consultancy business in Copenhagen and southern Sweden.

As Senior or Principal Consultant at NDA you provide strategic and operational support concerning regulatory affairs within drug development on a global, national or regional level. You manage and take part in complex and challenging projects from international companies or local start-ups within different therapeutic areas.

At NDA you will have access to our Advisory Board of ex-regulators and highly skilled colleagues in EU and USA. Take a look at some of your future co-workers: http://www.ndareg.com/capabilities/.

Responsibilities may include but are not limited to:
• Develop regulatory strategies to get products in early development phase to the market.
• Interpret guidelines and argue for the best strategies.
• Manage the preparation of regulatory files, e.g. MAA, NDA, IND etc
• Manage and take part in projects on the behalf of our clients.
• Participate in scientific advice activities and communicate with authorities.
• Networking, business expansion and client management

Read about some of your future colleagues: https://search4s.teamtailor.com/pages/welcome-to-nda-regulatory-services

• In-depth knowledge of regulatory strategies on a senior, advisory level.
• Vast knowledge of regulatory affairs within drug development in different countries and regions (e.g. Europe and US).
• Experience from pharmaceutical industry and/or medical agencies.
• Experience from complex project management roles or equivalent.
• Academic degree within life science.
• Excellent spoken and written English.

You are proactive, adaptable and confident in decision-making. You enjoy networking and actively contribute to business expansion.

NDA is a world leading regulatory drug development, pharmacovigilance, HTA and scientific communication consultancy.

We support life science companies all over the world and across all phases of development, from pre-clinical to post marketing, to the needs and requirements of regulators and payers alike. We work together with our clients to address key strategic regulatory and reimbursement challenges. Our scientific expertise covers all major therapeutic areas.

NDA has more than 150 employees with industry and regulatory agency backgrounds, supported by a network of over 1 000 scientific, clinical, regulatory and drug development experts.

www.ndareg.com

Varaktighet, arbetstid
The employment is with NDA, with placement in the Copenhagen or Malmö region. The position is open-ended (fast anställning), full-time, starting upon agreement.

Publiceringsdatum
2018-05-17

Så ansöker du
Sista dag att ansöka är 2018-06-14
Klicka på denna länk för att göra din ansökan

Kontakt
Anna Rennermalm anna@search4s.se

Företag
Search4S Dustgoat AB

Adress
Search4S Dustgoat AB
Johannelundsvägen 2
19461 Upplands Väsby

Kontorsadress
Johannelundsvägen 2

Jobbnummer
4150181

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