Manager Study Start Up and Regulatory Affairs

Job Description

The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on
regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection
through site initiation readiness. The manager actively assists senior management in securing new
business by participating to BDMs and contributing to proposals/budgets. They also provide strategic
regulatory guidance, training, coaching and mentoring to junior members; may be required to line
manage members of staff.

Leads study start-up and regulatory activities for assigned projects of medium to high complexity,
ensuring delivery aligned with timelines, quality standards, and regulatory requirements.

Accountable for end-to-end delivery of study start-up and regulatory milestones across assigned
projects.

Ensure collection, review for completeness/compliance, and tracking of essential documents for
Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate
or missing documents to ensure accuracy and completeness of information. Prepare study team
reports or updates regarding status of essential document collection, review and approval.

Ensure negotiation and execution of clinical site agreements, ancillary agreements as well as
amendments, in accordance with project requirements and country regulations and within the
projected delivery timelines.

Defines and implements study start-up and regulatory strategies at project level, ensuring
alignment with sponsor expectations, regulatory requirements, and operational feasibility.

Proactively identifies, assesses, and mitigates risks impacting study start-up and regulatory
timelines, ensuring timely resolution of issues.

Builds and maintains strong relationships with clients, regulatory authorities, and internal
stakeholders to ensure effective collaboration and delivery.

Ensure all team members assigned to the project for departmental deliverables are aware of the
tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify
and escalate any OoS.

Assist in securing new business or repeated business by participating to BDMs, developing and
reviewing regulatory sections of proposals, regulatory costing and budgets.

Provides strategic input into bids and contributes to winning new business opportunities

Provides coaching, guidance, and performance feedback to team members to support
development and delivery excellence.

Performs other work-related duties as assigned.

Qualifications

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
combination of education and experience.

6-8 years within pharmaceutical or CRO industry or Regulatory
body, of which at least 3 years in a leading/project management
role

Proven ability to successfully manage global projects

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 
• Integrity and trust: we do the right thing, especially when it is hard. 
• Drive and passion: we care about the outcome, because someone is waiting on it. 
• Agility and responsiveness: we move quickly, because patients cannot wait. 
• Belonging: everyone is welcome, and every voice counts. 
• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application.