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Title : NVA- Regulatory Consultant -425
State : Massachusetts   Date : Mar 15, 2019
Experience Level :  
Position Type : Regulatory Consultant      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Cambridge, MA


Job Title: Regulatory Consultant


Duration:  6+ months (extendable) contract on W2


Duties:


Lead development of regulatory strategies for all projects in the NIBR portfolio (both small molecule and biologics programs) assuring regulatory guidance is provided to teams from the time of Development Candidate (DC), through FIH and POC studies. The EDRD will lead all early regulatory submissions including preparation of INDs/CTAs for FIH and POC studies. The EDRD will also partner with DU RA representatives in supporting a smooth transition of programs into the Development portfolio, aligning transitions with the formation of a Development Global Project Team. The EDRD will lead the regulatory activities in planning for early Health Authority (HA) interactions for all ED. programs including pre-IND meetings, early scientific advice meetings (pre and post IND/CTA filing). The EDRD will provide global regulatory leadership identifying and evaluate issues, regulatory risks/gaps for projects and provide a regulatory strategy towards registration and provide this in Development Plans, in alignment with DU RA representatives.


Skills:


Experience in discovery research, preclinical pharmacology, toxiciology or other experimentally based discipline is a plus. Fluency in English as a business language. Additional language is an asset. Experience: 8-10 years total involvement in regulatory and drug/biologic development with at least 6-8 years in regulatory, spanning activities from preclinical development through Phases I-IV. 2-5 years additional drug development experience, including chemistry, pharmacology or toxicology experience. Prior experience in early development strategies strongly preferred. Excellent collaboration, communication and leadership skills. Ability to think outside the box. Ability to work closely with less experienced team members, mentoring and negotiating.



Education:


PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience. Prefer a strong background in molecular biology, biochemistry, or toxicology.

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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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