Regulatory Project Lead

Step up to the new challenge and take the lead in a diverse international regulatory environment!
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What we offer

You will have the chance to expand your knowledge on various local and European legislation and approaching each country’s specifications. Bring a real value to our worldwide patients by having a high level of impact on delivery of the early and late-stage pipeline.

Joining our consulting team means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

The Regulatory Project Lead provides regulatory support across the product life-cycle for pharmaceutical products (clinical development to market maturity).

  • Primary contact for delivery of submissions or strategy components for an assigned product in development or marketed product; planning own and submission team activities to ensure delivery to agreed time frames and appropriate content.
  • Responsible for the development and implementation of the submission strategy for major markets and non-major markets worldwide.
  • Provision of product’s life-cycle legalized documents, translations, samples and other requirements in accordance with local country legislation. Ensure the new process delivered is resource efficient across the central teams and local regulatory groups worldwide, with connectivity as needed to external systems (queries management).
  • Ensure quality of both own and submission team’s work and compliance with regulatory guidelines and process as they apply to the role. 
  • Work with staff from other functions and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidance, researching topics and resolving issues. 
  • Mentoring/coaching submission coordinators working on the Project Lead’s assigned products and reviewing their work output to ensure right first time submissions.

Profile

  • Degree in pharmacy or in biological or healthcare science qualification.
  • Global Regulatory submission experience - knowledge of regulatory agency guidelines and expectations for submissions.
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines and managing multiple submissions simultaneously.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
  • Fluent English is mandatory and another European language is a plus.
  • Ability to interpret and advice on guidelines and requirements on a global basis.
  • Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
  • Ability to gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Additional information

  • Remote status

    Flexible remote

We usually respond within a week

Or, know someone who would be a perfect fit? Let them know!

Some of your colleagues

Waterloo, Belgium

Drève Richelle 161
1410 Waterloo Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

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