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Regulatory Affairs Consultant

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

8+ years of experience in regulatory affairs, Working knowledge of ROW regulatory guidelines, Experience with Regulatory Information Management Systems, Knowledge of ASEAN markets' regulations is a plus.

Key responsabilities:

  • Plan and prepare regulatory submissions
  • Liaise with cross-functional team members
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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

  • 8+ years’ experience in handling life cycle management of approved drug products (like-Tablets, Syrups, Ointments, Nasal Sprays) for ROW markets.
  • Working knowledge of ROW regulatory guidelines, including post approval requirements.
  • Knowledge of ASEAN markets’ regulatory legislations would be an added advantage.
  • Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Lead/Plan, prepare, review and strategize minor labelling variations & safety labelling variations across the ROW countries as per business requirements.
  • Experience in handling CMC & labelling related health authority queries.  
  • Liaise closely with cross-functional members with aligned responsibilities and proactively provide status updates to designated stakeholders.
  • Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
  • Experience on Artwork Management Tools like Vista link would be an added advantage.
  • Strong listening and communication skills would be desirable.
  • Ability to work independently without the need to supervise.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Communication
  • Active Listening

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