Manager, Regulatory and PV Delivery

The Manager, Regulatory and PV Delivery is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They actively assist 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.
Main responsibilities:

- Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.

- Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.

- Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.

- 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.

- Prepare client’s invoices and review/approve vendor’s project invoices

- Provide training, coaching and mentoring to junior members of staff

- Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.

- Prepare and/or contribute to the Regulatory Newsletter and update regulatory database
when new information is available.

- Ensure collection, QC review and timely dissemination of all regulatory intelligence related to
departmental deliverables. Support interpretation and impact analysis on legislation.

- Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery

- Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan)

- Minimum 3 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.

- Expert knowledge of ICH GCP and/or GVP and most relevant legislation/ local requirements for territories of competency.

Why PrimeVigilance

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.
remote

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a glob