Head of Regulatory Affairs Emea - Gent, België - Argenx

Argenx

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA.

PURPOSE OF THE ROLE

The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT).

This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute to build and grow the organization across the region.

The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization at a regional and country level across the region.

In close collaboration with other functional heads and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others.

ROLES AND RESPONSIBILITIES

Establish the EMEA regulatory strategy for marketed and pipeline products and ensure it is in line with the global regulatory strategy, taking into account the diverse needs of the EMEA region
Perform or oversee the preparation of the registration dossiers and adequate response to all agency questions
Ensure the labelling components relevant to the region are based on the company core datasheet and prepared in conjunction with the EMEA team
Secure regulatory approvals within the EMEA region, on time as per plan, ensuring crossfunctional partners are fully aware of procedures and timelines to guarantee organizational readiness
Proactively seek out robust crossfunctional input to help inform decisionmaking and appropriate tradeoffs regarding labelling, procedural steps, and overall probability of regulatory success
Collaborate with supply chain, CMC, distribution, and market access colleagues to ensure regulatory strategies are aligned with broader organizational strategies
Monitor regulatory approvals, trends, and dynamics in clinical areas of interest to the company, and proactively share regulatory intelligence internally, as appropriate
Provide strategic, operational and tactical regulatory insight on preapproval activities, including EAP development and rollout
Serve as the regulatory affairs business partner to local commercialization teams on all matters related to product promotion and materials review
Partner with medical, legal, quality, PV, market access and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
Serve as a conduit between business strategy within the EMEA team and the broader global regulatory and development teams
Support the EMEA business in all other regulatoryrelated activities, this includes local regulatory activities in individual member states, where needed.
Oversee regulatory affairs vendors involved in filings and help ensure high quality interactions with the EMA and other EMEA agencies
Lead and develop the EMEA regulatory team.

SKILLS AND COMPETENCIES

Prior experience in the buildout of organizations and the creation of commercialization infrastructure from scratch
A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in Europe
Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines in Europe, including direct experience leading endtoend regulatory submissions
Affinity with science and ability to interact with scientists and clinicians, internally and externally
Direct experience interacting with regulatory authorities across EMEA, and a successful track record of interactions among regulatory agencies
A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills in English and at least one other major EU language, to succeed within a multicultural and multilingual global environment
You are a connector, building relationships and partnering across the organization to achieve the company goals
You excel in a fastpaced, resultsdriven, highly accountable environment
You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done
You show strong leadership with proven ability to build, motivate and develop a team
You resonate with the values of argenx and you are ready to drive the Company Culture
You combine strategic thinking with the ability to execute, both individually and by leading teams, to achieve operational excellence in the face of challenging goals
Is agile and demonstrates adaptability, comfort with ambiguity, trustbuilding, and resilience
Demonstrable experience with project management, proactive planning, priority setting, and securing alignment
Ambitious, inquisitive naturally, a qui