Senior Consultant CMC small molecules, NDA Regulatory Service AB
Search4S Dustgoat AB / Apotekarjobb / Upplands Väsby
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hela Sverige NDA is Europe's leading regulatory drug development consultancy. As Senior Consultant within CMC small molecules you provide NDA's clients with strategic advice and operational support on chemistry manufacturing and control within pharma. Your assignments will vary but include e.g:
• Provide regulatory advice on CMC development strategies for drug development from early stages through marketing authorization applications, line extensions and variations.
• Provide advice on and author CMC documents like IMPD & IND.
• Provide advice and support client in scientific advice procedures.
• Author, review and expert signature CMC overview (Module 2.3 and 3) responses to competent authorities.
You will work with both decentralized and centralized procedures (mainly EU). The position as Senior Consultant is perfect for you who wish to work with a variety of tasks, products & people and still be an active team member at NDA with opportunities to personal growth.
The employment is with NDA, with placement at the office in Upplands Väsby. The position is permanent, open-ended and full-time, starting upon agreement.
• Academic degree in pharmaceuticals, chemistry or equivalent.
• Several years of work experience from CMC small molecules or corresponding role at a relevant authority.
• In-depth knowledge & understanding of CMC development
• In-depth knowledge of European regulations & guidelines. Knowledge of US regulations is meriting.
• Excellent spoken and written English.
To succeed as Consultant at NDA you are open to changes and adapts easily to new tasks, situations and people.
Is this you? Welcome with your application!
NDA is Europe's 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.
NDA supported over 40% of the new medicinal products that were approved in the EU during 2013-2016.
www.ndareg.comVaraktighet, arbetstid
This position is full-time, open-ended. It is an employment with NDA Regulatory Services AB in Upplands Väsby with in-house assignments.
Publiceringsdatum2017-03-10Så ansöker duSista dag att ansöka är 2017-04-02
Ange följande referens när du ansöker: NDA CMC
KontaktAnna Rennermalm
anna@search4s.seFöretagSearch4S Dustgoat AB
AdressSearch4S Dustgoat AB
Johannelundsvägen 2
19481 Upplands Väsby
KontorsadressJohannelundsvägen 2
Jobbnummer 3368989
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