Manager Study Start Up and Regulatory Affairs

📋 Description

• Developing the strategy based on regulatory requirements and overseeing all SSU deliverables from
• Leading study start-up and regulatory activities for assigned projects of medium to high complexity.
• Accountable for end-to-end delivery of study start-up and regulatory milestones.
• Collection, review for completeness/compliance, and tracking of essential documents for Study
• Negotiation and execution of clinical site agreements, ancillary agreements, and amendments.
• Identifying, assessing, and mitigating risks impacting study start-up and regulatory timelines.

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and
• 6-8 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a
• Proven ability to successfully manage global projects.

🎁 Benefits

• Collaborative, international team environment.
• Values-driven culture emphasizing Quality, Integrity, Drive, Agility, Belonging, and Collaboration.
• Commitment to work-life balance.
• Opportunity to make a difference in bringing treatments to patients.
• Flexibility and teamwork.