Thursday, December 14, 2017

Careers

eVenus Pharmaceutical Laboratories Inc. is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. We offer a comprehensive benefit package, including major medical, dental, life insurance, 401(k) and the opportunity to grow within a dynamic environment. To learn more about our parent company, please visit: http://www.hrs.com.cn/english/

Please check our current job opennings in this section.


Regulatory Affairs Manager to Associate Director Positions

Jiangsu Hengrui Medicine Co., Ltd is a leading pharmaceutical drug manufacturer in China. Hengrui’s corporate mission is to provide critical care medicine, anesthetic and oncologic drug products. eVenus Pharmaceutical Laboratories, Inc. (eVenus), Princeton, New Jersey functions as the official US Subsidiary and Agent for Hengrui and liaison before all regulatory agencies including US / EU Regulatory Filing, Compliance, Pharmacovigilance, Patient Safety and Quality Assurance, for  marketed products. We have multiple openings.

The Generic Drug Division at eVenus is currently seeking to hire distinguished regulatory professionals at Specialist to Associate Director level; dependent upon his/her background and experience.

Major responsibilities:

  1. Develop and implement regulatory CMC strategies for generic drug product applications.
  2. Lead activities including managing, planning, writing and reviewing CMC sections of all regulatory submissions (ANDAs, INDs, 505(b)(2) NDAs, MAAs, ASMFs, DMFs, CEPs, and briefing documents) to support generic product registrations in the US and EU.
  3. Coordinate the preparation of deficiency responses to regulatory agencies.
  4. Provide regulatory guidance and scientific advice to cross-functional international teams on drug substance and drug product development.
  5. Assess post-approval changes for existing commercial products and provide guidance on regulatory impact.
  6. Interact with US and EU regulatory agencies.
  7. Compile submissions in eCTD format.

Requirements: 

  1. Bachelor’s degree in Chemistry or in a life sciences discipline, advanced degree is preferred
  2. 3-10 years of generic pharmaceutical development experience, with at least 3 years of experience in generic regulatory affairs: US (DMF/ANDA/NDA) and/or EU submission.
  3. Demonstrated ability to provide regulatory & scientific direction in starting material selection, impurity control, polymorphism evaluation, formulation & process development using QbD approach, and microbiological assessment, etc.
  4. English and Chinese bilinguals are strongly encouraged to apply. 

Email Resumes Only: sharleen.gu@hengruiusa.com