Regulatory Affairs Senior Manager, Biosimilars

Jobdescription

For our client, an international biotech company based in Baar, we are looking for a Regulatory Affairs Senior Manager to join the Biosimilars Business Unit.

The person will be responsible for leading regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialisation.

General Information :

• Start date : ASAP / 02.09.2024
• Duration : 1 year
• Extension : possible, to be discussed
• Workplace : Baar
• Workload : 100%

Tasks and responsibilities :

• Regulatory representative for assigned projects, programmes and processes, responsible for securing stakeholder alignment.
• Provide oversight and reporting on project progress to regulatory management.
• Responsible for oversight of regulatory vendors, including :
• Oversight of vendor activities on a day-to-day basis, ensuring successful execution of operational activities, tracking, and archiving for assigned products.

Decide on activity prioritization for vendor

• Implementation of vendor oversight plans, including establishment and management of KPIs, and, tracking and monitoring of deviations, and reporting of metrics.
• Leading the vendor(s) and for driving identified innovative process change for improved efficiency.
• Provide training and support to regulatory colleagues, in-country RA leads, and vendors as applicable, ensuring In-country RA leads training and access is maintained.
• Management and oversight of regulatory contracts, SOWs, and PO’s including renewal activities, working closely with procurement, finance and medical operations.
• Lead assigned process development or improvement activities; planning, authoring, regulatory and cross functional alignment, documentation, implementation, and training as needed.
• Manage and support regulatory quality deliverables, including regulatory KPIs, process development and SOP management, deviation and CAPA management, change controls, inspection support, regulatory intelligence management.
• Support regulatory submission science and information management with document management, quality control, tracking and publishing activities.
• Monitor and assess regulatory policy, guideline and procedure changes assessing potential impact, support the team to keep abreast of current regulatory requirements
• Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of Biogen and to ensure regulatory compliance
• Responsible for planning and implementing defined regulatory strategies, and co-ordination and filing of all appropriate regulatory submissions for assigned projects and programs.
• Oversight and management of regulatory in-country A&Ds, workload assignments & deliverables, prioritisation, and troubleshooting.

Working closely with affiliate and distributor teams to ensure successful execution of biosimilar regulatory responsibilities.

Responsible for the development of core aRMMs and for leading their customisation, submission, approval and dissemination across markets.

Responsible for the implementation of updates to approved aRMMs

• Responsible for implementation of Biogen’s Biosimilar labelling strategy, liaising with cross functional and local regulatory teams, and ensuring strategic partner alignment for successful execution
• Oversee regulatory review of promotional materials, sales training materials and other external communications, negotiating regulatory compliance within established risk parameters
• Provide regulatory support and guidance to brand teams, supply & planning, quality, manufacturing, logistics functions on regulatory activities and issues as needed

Your profile :

• BS degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject
• 6 to 8+ years pharmaceutical / biotechnology industry with 4 to 6+ years regulatory experience
• SME in regulatory processes
• Good knowledge of applicable regulations, and submission standards / requirements. Ability to interpret regulations and guidelines.
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
• Strong communication and project management abilities in global and virtual teams
• Strong interpersonal skills and the ability to collaborate effectively across project teams, Biogen’s innovator business and with vendors.
• Ability to work independently with minimal supervision
• Competent in the use of electronic document management tools.
• Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected.
• Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks.
Vor 27 Tagen