Freelance Manager Clinical Services

ProPharma Group is an industry-leading, single-source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

This is a freelance remote position and the candidate will work from home.

This is a 3-month full-time freelance remote consulting position.

The work may include, but is not limited to:

• Participate in weekly CST and CRO meetings as Glogal Regulatory Affairs CST representative
• Oversee CRO RA activities with CRO RA counterparts
• Manage and coordinate regulatory /clinical activities with CST and GRA stakeholders
• Maintain dashboard and inform GRA stakeholders as necessary
• Update eDMS archiving (CTA folder)  as necessary

• Excellent understanding of registration procedures and requirements as well as product life cycle management from regulatory affairs perspective. 
• To have knowledge about regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
• Strong project management skills.
• Having an open eye for the needs of your customers and the ability to adjust to these needs.
• Able to work to deadlines and solving issues in a pragmatic and proactive way.
• Ensuring you are able and willing to dig into the details yet keeping an eye on the overall goal of the project.
• At least 4 years of experience in Regulatory Affairs from the pharmaceutical industry, preferably at both subsidiary and headquarter level.
• Strong communication skills (oral and written) in the English language.

All candidates must be legally eligible to work in European Union.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***