Regulatory Affairs Associate Director - EU Regulatory Lead - FSP Client Dedicated

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Affairs Associate Director - EU Regulatory Lead– Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to lead innovative projects and provide strategic regulatory intelligence that makes a real difference in product development. As a Regulatory Affairs Associate Director, you'll play a key role in guiding product development from preclinical stages through registration and optimization. You will provide regulatory expertise and client interface, offering strategic guidance and updates on country, regional, and global regulatory intelligence. Routinely act as an adviser to other units within the department and liaise with local country regulatory authorities. Responsible for acting as a liaison with internal and external clients in the provision and marketing of these services.

For the expansion of our regulatory team, we are looking for an EU Regulatory Lead, to support on of our clients on the rapid growth needed for successful commercialisation. This role with cover primarily the EU and will require involvement in the other territories (e.g. UK, Switzerland, Israel and the Middle East...etc.).

The EU Regulatory Lead, is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. 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 commercialisation. In close collaboration with other functions 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, and post-approval regulatory activities, among others.

What you’ll do

• Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities
• Help guide the organisation on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings with EMA / applicable agencies of the EMEA region
• Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators
• Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings, and other areas as requested
• Provide regulatory leadership with post-approval activities
• Monitor, interpret, and communicate changes to the global regulatory landscape
• Serve as the regulatory affairs business partner to local commercialization teams
• Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
• Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams
• Acts as a global lead in providing review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as lead subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Oversees matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Participates in and leads launch meetings, review meetings and project team meetings. Leads departmental initiatives/project teams.

Education and Experience Requirements

• Advanced degree required; PhD or PharmD strongly preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years). Minimum 10 years’ experience in regulatory affairs within pharmaceutical organizations, with a strong emphasis on EMA regulatory frameworks. Must include at least one end-to-end regulatory submission process, preferably with the centralised procedure.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Prior experience working in rapidly growing pharmaceutical organizations is advantageous
• A thorough understanding of the drug development lifecycle with demonstrated expertise in orphan drug development, along with knowledge of the evolving global regulatory landscape, particularly across Europe and other territories (e.g. Switzerland, UK...etc.)
• Demonstrated ability to lead and coordinate the development of critical regulatory documents essential for the approval and life cycle management of medicinal products, with a focus on EU regulatory strategy, including Paediatric Investigation Plans (PIPs) and other key submission components.
• Established track record of successful engagement with regulatory and health authorities, including preparation for and participation in regulatory interactions.

Knowledge, Skills and Abilities

• Mastery of English language (written and oral) communication skills as well as local language where applicable
• Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
• Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Professional negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Outstanding analytical, investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting
• Sharp executive presence and consultation and presentation skills

Working Conditions and Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.