A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: We are currently seeking a Regulatory Expert for APIs - based in Altdorf, Switzerland. You will act as the Regulatory Expert to drive and support regulatory submissions of active pharmaceutical ingredients (APIs) and chromatography materials. You ensure that relevant changes to product registrations and listings are properly notified to the relevant authorities and maintained. In-depth knowledge about requirements for filing, registration, and notification of pharmaceutical starting materials, excipients and APIs are desired.
You work in a global regulatory team and drive close interaction with the quality and operational units at the site. You lead collaboration with internal experts within the Business areas and across the business organization to gather data and support efforts. You support the manufacturing site to comply with regulatory requirements and good regulatory practices. You participate as the Regulatory Representative in the product development process to develop and execute regulatory strategies, assessments and plans and may interact with external customers.
Your key responsibilities include:
Maintain the regulatory activities for APIs and other relevant products (eg., chromatography materials) at the site
Lead the preparation and review documents for submission to Regulatory Agencies in compliance with requirements, to ensure their timely written submissions
Responsible for technical writing of DMF documents in the dedicated document management system
Conduct activities in the e-submission system Eldorado and RIMS (regulatory information management system)
Create annual reports for the APIs at the site
Lead the issuance of Letters of Authorization (LoA)
Support preparation of Product Quality Reports and other regulatory reports based on quality data
Perform regulatory assessment of changes per the change control process
Prepare and perform Halal Audits for the site on an annual basis,
Support local regulations in support of new APIs, and products requiring related regulatory support
Drive the creation policies and operating procedures to strengthen regulatory compliance
Support the regulatory tracking databases for planning, scheduling, submissions, and action dates, and overall project management
Prepare statements and answers to customer requests
Lead the provision of responses to customer regulatory queries
Who you are:
Bachelor level (or higher) of education in pharmacy or life sciences with a strong emphasis in chemistry or biology
Ideally several years (ideally 3 – 5) of relevant industry experience and/or regulatory affairs related to APIs, pharmaceutical excipients and process materials
Experience in quality functions such as audit hosting, product quality reviews, and other key quality responsibilities
Experience supporting technical customer requests and queries
Knowledgeable of US FDA and EU drug regulations, specifically for submissions in CTD format. Knowledge of regulatory landscape of other important regions, e.g., in Asia.
Expertise in QC and QA for pharmaceutical starting materials and requirements of pharmacopeias
Experience in submissions in CTD format. Experience in e-submission tools is welcome
Knowledge of regulations relevant to pharmaceutical starting materials, quality requirements and preferably processing of APIs and excipients in general. You should be well-versed in regulatory trends for pharmaceutical raw and starting materials.
Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems such as Oracle or SAP. Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.
Job Requisition ID: 202302
Location: Uri - all
Career Level: C - Professional (1-3 years)
Working time model: full-time
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!