Regulatory Technical Manager
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Proclinical are recruiting for a Regulatory Technical Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Basel.
- Accountable for preparation and upkeep of CMC documentation in internal document management systems and assist with associate actions.
- Handle regulatory changes throughout the product life cycle.
- Serve as a representative PTR on any other cross-functional teams, advise cross-functional teams regarding regulatory needs and collaborate with diverse partners and personalities.
- Partake in driving effectiveness by simplifying, trying new wats and cutting out waste.
- Assist the technical regulatory division on the implementation of proposal-linked and administrative actions for international technical registrations.
- Suggest methods for earliest possible approvals of clinical trials applications.
- Guarantee regulatory compliance together with both local and international technical functions and examine technical change records for regulatory impact.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a scientific field, though an advanced degree would be advantageous.
- Familiarity with technical regulatory affairs, with profound knowledge on national and global regulations and biotechnology.
- Capable of handling projects.
- Communication skills both verbally and in writing.
- Fluency in the English language with knowledge in German would be beneficial.
- Computer literacy.
- Works well in teams.
- Able to work in a diverse and changing, international setting.
- Capable of prioritising workload.
- Attain an open, curious and willing manner to explore new ways of working.
- Ability to take risks.
- Capable of making own decisions, assume ownership and resolve issues.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.