Overview
Contributes to define, develop, and support the Regional (Europe & Canada (EUCAN) or Growth & Emerging Markets (GEM)) strategies to maximize regulatory success and strengthen the product development plan in support of enabling patient access, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management. Collaborates with the global, regional, and local team to enable patient access in alignment with program objectives and timely approval of investigational applications and life-cycle management applications, while maintaining full compliance with applicable regulatory requirements. May lead or contribute to the Submission Working Group and represents the region as needed on global and project teams. Supports interactions with health authorities in the region for products within their responsibility.
Accountabilities
* Demonstrates leadership behaviors.
* Collaborates with Global, Regional counterparts, Local Regulatory Affairs, to manage all aspects of regulatory activities throughout the product life cycle.
* May be regulatory lead or support a more senior regulatory lead for assigned assets and/or projects.
* May present regional regulatory strategies to leadership/senior management.
* Stays current with regulations and guidance in the region for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain regulatory compliance.
* Provides regulatory expertise on drug development, registration and / or post-marketing compliance and life cycle management.
* Monitors the relevant regional regulations and guidance for programs in area of responsibility and participates in the review of new legislation and regulatory procedural guidelines, as applicable.
* Participates, as appropriate, and authors/reviews internal procedures and processes.
* Actively pursues the tracking and fulfillment of post marketing commitments.
* Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
* Supports Access to Medicines initiatives to develop and implement innovative patient access strategies.
* Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams, company’s consultants and Business Partners as required.
* Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments of trends, regulations and changes related to assigned programs.
* Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility.
* Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
* Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required.
* Oversees LOC interactions with Health Authorities in Growth and Emerging Markets for responsible programs.
* Interacts directly with Health Authorities (EUCAN), as required. May represent in Health Authority meetings. Effectively communicates and manages meeting outcome and next steps, as required.
Education, Competencies and Skills
* BSc. Advanced scientific related degree preferred; BA accepted based on experience.
* A minimum of 4 years of experience in drug regulatory affairs preferably within the EU or GEM region.
* Experience with advanced therapeutic medical products (Cell and gene therapy) will be advantageous.
* Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in all phases of development for Emerging markets and/or EUCAN Markets (relevant to role), as well as leading interaction with Health Authorities.
* Has basic regulatory procedure knowledge with major health authorities in the region.
* Analyzes issues with attention to detail and makes reasoned recommendations.
* Promotes an inclusive culture and expresses empathy for others.
* Is able to carry out assigned activities within reasonable time.
* Adapts to changing circumstances and is able to build and maintain relationships.
* Receives and gives feedback; expresses ideas, questions, and disagreement.
* Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
Job Requirements
If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Vladyslav Kadaiev on +41 58 307 2092. Due to Swiss work permit restrictions, we can only consider applications from EU citizens or holders of valid working permit in Switzerland.
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