Regulatory Affairs Manager

Work Schedule

Environmental Conditions

Job Description

Discover Impactful Work:

At Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. As a world-class organization, we pride ourselves on our integrity, intensity, innovation, and involvement.

The biologics drug substance manufacturing site of Lengnau is part of the world class Pharma Services Group (PSG) of Thermo Fisher Scientific. We are looking for an experienced Regulatory Affairs Manager for our complex and highly regulated environment, based in Switzerland. You will have a real-world impact and will be supported in achieving your career goals. PSG offers to our Customers a powerful platform for their drug development with advanced technologies, strategic guidance, and flexible solutions. The successful candidate will take their place within the engaged and knowledgeable Thermo Fisher Regulatory Community of 70+ regulatory professionals with significant industry expertise in regulatory CMC/quality and compliance​.

Take part of our entity's growth by enhancing our Regulatory Compliance and Services offering for clinical and commercial biological products and providing state-of-the-art deliverables to our Customers for domestic and international jurisdictions.

Additionally, while benefiting from the site quality environment, there will be opportunities to further explore and collaborate on strategic regulatory compliance activities with local & foreign health authorities.

A day in the life of:

Regulatory Knowledge and Expertise

• Be aware of Swiss current regulations & trends impacting our local business and influence externally by leaning into professional industry trade association working groups.
• Stay abreast on procedural & CMC related regulations by monitoring relevant pharmaceutical regulations by attending reputable congress and leveraging from internal community of practices.
• Foster collaboration and leverage internal synergies for regulatory compliance & services harmonization and best practice across the biological manufacturing network.

Regulatory Compliance Activities

Site Regulatory Compliance

• Define site licensing strategies, prepare and submit applications for domestic and foreign accreditations.
• Handle SMF updates and submissions.
• Engage in regulatory inspections preparation, participation and answers as well as in Customers’ key audits.
• Support Change Control process by assessing regulatory impact & requirements.
• Set-up and optimize necessary regulatory systems and SOP in relation to these activities.
• Ensure adequate archiving of relevant documents.

Product Regulatory Compliance

• Ensure Customer's product registration information translation into production and quality control master documents.
• Perform gap analysis between customer’s product CMC information and operations practices within new product introduction and regulatory inspections preparedness.
• Support Change Control process by assessing regulatory impact & requirements.
• Collaborate to components compliance and evolving regulations by partnering with Quality Control.
• Set-up and optimize necessary regulatory systems and SOP in relation to these activities.
• Ensure adequate archiving of relevant documents.

Regulatory Services

• Promote and capture regulatory services as part of our integrated offering concept while partnering with Sales & Business functions.
• Draft quotations per available tools in relation with Quotes function.
• Provide project regulatory liaison within multi-sites integrated offerings and Customer’s regulatory counterpart. 
• Counsel on regulatory matters and define regulatory strategies per latest standards.
• Author and review CMC / CTD M3 - Quality documents for clinical & commercial applications relevant to EU (IMPD-MAA-Variations), US (IND-BLA-PAS-CBE-AR) and RoW markets.
• Assist in deficiency letters/questions from regulatory agencies.
• Be accountable for yearly assigned regulatory revenue target, track invoices through revenue recognition in relation with Finance.

Regulatory Reporting

• Accountable for ensuring adherence to regional key deliverables' plan feeding into Global Regulatory Affairs reporting (data entry) including regulatory services metrics.

Keys to Success:

Education

• Advanced degree or equivalent experience in European Life Sciences (e.g. Biology, Microbiology, Pharmacy, Chemistry).

Experience

• Minimum 10 years of relevant pharmaceutical regulatory affairs in the drug substance large molecule space (including CMC technical dossiers writing) with cGMP manufacturing operational exposure in biological environment.

Knowledge, Skills, Abilities

• Knowledge of Swissmedic & European regulatory landscape (including GMP essentials) and exposure to professional community such as CASSS, TOPRA.
• Well-versed on biologics CMC regulatory requirements for clinical and commercial bulk drug substances according to EMA, FDA, ICH primarily as well as having an understanding of the respective registration procedures.
• Advanced organizational skills with ability to multi-task in a fast-paced environment and effective time management and prioritization skills
• Agile in interacting with management & leadership as well as customers, regulators and other stakeholders.
• Customer-centric attitude with business sense.
• Ability to work with cross-functional teams as well as in a matrixed environment.
• Effective verbal and written communication skills in English and German.
• Rigorous and attention-to-detail skills, especially in the completion and review of regulatory dossiers.
• Ability to evaluate and resolve technical-regulatory issues, advise on regulatory solutions and engage in quality issues resolution.
• Sound skills in typical office electronic platforms and IT agility.

Physical Requirements / Work Environment

Adhere to OHS policies and procedures and ensure safe and healthy workplace environment.