Manager, Study Start Up and Regulatory Affairs

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Formulate regulatory strategies and manage the coordination and oversight of study start-up deliverables, from site selection to site initiation readiness.

• Direct study start-up and regulatory efforts for assigned projects of medium to high complexity.

• Oversee the complete study start-up and regulatory milestones from beginning to end.

• Gather, evaluate, monitor, and resolve issues related to essential study documents.

• Create reports and updates for the study team regarding the collection, review, and approval status of documents.

• Negotiate and finalize clinical site agreements, ancillary agreements, and amendments.

• Identify, evaluate, and address risks that may impact study start-up and regulatory timelines.

• Establish and nurture relationships with clients, regulatory bodies, and internal stakeholders.

• Delegate departmental responsibilities, oversee budgets and hours, and escalate work that falls outside the scope.

• Engage in business development discussions and assist in proposals, regulatory sections, cost estimations, and budgets.

• Offer strategic input for bids and aid in securing new business opportunities.

• Provide coaching, mentorship, and performance feedback to team members.

• May be responsible for line managing staff and undertaking other assigned tasks.

⛳️ Requirements

• Advanced degree in Chemistry, Life Sciences, Nursing, or a comparable mix of education and experience.

• 6–8 years of experience in the pharmaceutical or CRO industry or within a regulatory organization.

• A minimum of 3 years in a leadership/project management position.

• Demonstrated capability to effectively manage global projects.

• Familiarity with regulatory requirements and processes related to clinical study start-up.

• Experience with the process from site selection to site initiation readiness.

• Proficiency in managing study start-up and regulatory activities for projects of medium to high complexity.

• Skill in overseeing the collection, review, compliance, and tracking of essential documents.

• Competence in negotiating and executing clinical site agreements, ancillary agreements, and amendments.

• Ability to define and put into action study start-up and regulatory strategies.

• Skills in risk identification, assessment, and mitigation.

• Capability to monitor project budgets and recognize out-of-scope work.

• Experience in contributing to business development meetings, proposals, regulatory costing, and budgets.

🏝️ Benefits

• Collaborative, international team environment.

• Opportunities for career advancement.

• Flexible working culture.

• Emphasis on work-life balance.

• Opportunities for coaching, guidance, and mentoring.

• A passionate and cooperative team of experts.

• An inclusive workplace where every voice is valued.