Medical & Regulatory Affairs

From strategy to execution.

How can we help our clients with Medical & Regulatory Affairs?

Our Regulatory Affairs consultants will take care of the communication between our clients and regulatory authorities, and between different departments within our clients’ company. They will also give strategic advice to make sure the products meet all regulatory requirements and help companies obtain marketing authorisation.

Meanwhile, Pauwels Consulting’s Medical Affairs specialists will manage the relationships with different stakeholders (medical experts, thought leaders, healthcare professionals, …), gather and process scientific data and publish reports, work on research initiatives, … to ensure our clients’ trustworthiness as a scientific partner is clearly communicated.

What is our added value as Pauwels Consulting?

Our Medical & Regulatory Affairs consultants have a thorough scientific and regulatory knowledge and a broad skill set. They develop strategies that are widely supported within the entire organisation, succeed in mobilising stakeholders and are always up to date on changes in regulations regarding safety, data integrity and more.

Our consultants are persistent, have attention to detail and possess great communication, negotiation and project management skills. Our people look forward to putting these skills to work on their next project.

The roles

We are always looking to strengthen our team with the following experts:

Medical & Regulatory Affairs Manager

Our Medical & Regulatory Affairs Managers often serve as the primary regulatory contact for our clients. They help set up regulatory strategies, and they publish and submit clinical and regulatory documents. Their main duty is to manage regulatory timelines and resources to achieve our clients’ deliverables on time and within budget.

Our Managers work in internal and external project teams. They provide strategic input, and they work closely together with senior regulatory staff to plan, prioritise and coordinate regulatory document preparation and submission based on applicable global regulations.

Regulatory Affairs Officer

Our Regulatory Affairs Officers assist our clients with the compilation and submission of regulatory documents regarding new applications, variations, renewals, … to the local, regional and global regulatory authorities.

They build and maintain standard Regulatory Official Files and Marketing Authorisation filing and approval binders according to local SOPs.

Data Integrity Engineer

Our Data Integrity Engineers study the entire production process of sensitive products to evaluate whether all data linked to GxP systems (QC and production) and processes are treated and stored as prescribed in the data integrity requirements.

CSV Expert

Our CSV Specialists plan, write, implement and review the Computer Systems Validation protocols in highly regulated manufacturing and pharmaceutical environments. They make sure and provide proof that all computer-based systems are operating as intended according to the regulatory requirements.

“The Regulatory Affairs Operations team is very important at the start of the product management process. We mainly work behind the scenes, but we have a lot of impact. We contribute to the launch of products, we maintain good relationships with the authorities and we ensure that we can get new projects started faster.”
Emanuelle Lefebure

Pharma Consultant – Regulatory Affairs Operations

Are you interested?

Do you love Medical & Regulatory Affairs and are you looking for a new challenge? Let’s get in touch!

Sandy Beirnaert
Sandy Beirnaert Recruitment Consultant Life Sciences