Description
The Role:- Generate CMC documentation presented in the required format in accordance with agreed timetables for worldwide submissions
- Obtain information that supports the regulatory documentation
- Coordinate the assembly of submission ready documents to support lifecycle submissions
- Keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments
Your Profile:
- Strong IT acumen
- Fluently spoken and written English and Swedish
- Experience in Pharmaceutical Production, Quality Assurance, Quality Control, Product Maintenance, or Regulatory Affairs
- Degree in a Life Sciences Area
Preferable Skills:
- Comfortable working collaboratively with relative stakeholders, both internal and external
- Knowledge of document management systems / electronic publishing software
- Ability to work with short and/ or changing timelines
- Ability to manage expectations of others / strong communication Skills
Please apply with an updated version of your CV in English and we will contact you shortly should you fill the above specifications.
Key Words: CMC, Regulatory Affairs, Regulatory CMC, Pharmaceutical, Pharmacy, LEAN, Electronic CMC, CMC Documentation
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