Manager Study Start Up and Regulatory Affairs

Ergomed Group; Lisboa; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Ergomed Group, a specialist CRO focused on rare diseases and oncology, seeks a Manager of Study Start Up and Regulatory Affairs in Lisbon to lead SSU and regulatory strategy for medium to high complexity trials. You will coordinate site initiation activities, negotiate agreements, manage timelines and budgets, and mentor junior staff while contributing to bids and proposals.

The role requires a graduate degree in Chemistry or Life Sciences and 6–8 years in pharma or CRO, with global project

Competenze

• Experience leading regulatory strategy and SSU activities.
• Proven ability to manage global regulatory projects.
• Strong coaching and mentoring skills for junior team members.

Mansioni

• Lead study start-up and regulatory activities for assigned projects.
• Coordinate and oversee SSU deliverables from site selection to initiation readiness.
• Negotiate and execute clinical site agreements and amendments.
• Monitor budgets, timelines, and resource allocation; escalate risks.
• Provide strategic regulatory guidance and contribute to bids and proposals.
• Mentor and develop junior staff; contribute to training.

Conoscenze

Regulatory project management

Stakeholder management

Team coaching

Regulatory strategy

Formazione

Graduate degree in Chemistry or Life Sciences

Descrizione del lavoro

Manager Study Start Up and Regulatory Affairs

• Full-time
• Department: Study Start up and Regulatory Unit

Medicine moves forward here. So willyou.

Ergomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, dataqualityand the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported.

If you wantworkwith purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

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 escape 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.

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

When you joinErgomedGroup, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin 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 theoutcome, becausesomeone is waitingonit.
• Agility and responsiveness:we movequickly, becausepatients 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.