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Regulatory Affairs Consultant

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
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Offer summary

Qualifications:

Minimum 5 years of Regulatory Affairs experience, Knowledge of Safety Labelling changes, Experience with CCDS creation or updates, Familiarity with Veeva RIMS and TVT Tool is a plus.

Key responsabilities:

  • Manage safety labelling changes
  • Create or update Common Technical Documents (CCDS)

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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.

Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates

Experience:

1. Regulatory Affairs Experience – Minimum 5 years - EU/UK/CH/AU/NZ:

- Safety Labelling changes with impact on Product Information and management of AW updates from an RA perspective

- CCDS creation or updates prior experience preferable

- Change control assessments

- Experience working on Centralized products is a plus

2. Veeva RIMS Knowledge.

3. Knowledge in using TVT Tool is a plus.

Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety / Labelling changes, including CCDS creation or updates

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

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