Senior Manager - Global Regulatory Affairs (m/w/d) 100%
For our client, a leading provider of drug development and manufacturing solutions in the pharmaceutical and biotech industries, we are looking for a Senior Manager, Corporate Regulatory Affairs. In this role, you will be responsible for overseeing and harmonizing regulatory affairs processes across multiple sites, ensuring compliance with international regulations, and supporting the development of innovative drug products and substances. This is an exciting opportunity to contribute to the success of a dynamic and fast-growing company at the forefront of life sciences
Responsibilities:
- Assist in the development and implementation of a standardized Regulatory Affairs (RA) framework across all sites
- Ensure regulatory compliance for products, taking into account specific customer requirements
- Advise local Regulatory Affairs and CMC (Chemistry, Manufacturing, and Controls) teams on developing regulatory strategies for new projects, in collaboration with internal and external partners
- Guide and support the preparation, submission, and maintenance of regulatory documents (e.g., DMFs, CMC documentation for INDs, IMPDs, NDAs, MAAs)
- Provide hands-on support for the application of corporate RA standards at various locations
- Coordinate regulatory activities across all RAC teams during CMC process development and provide consultation to project teams on regulatory matters
- Lead the corporate RAC organization as part of the Quality division
- Oversee the RAC chapter in the Corporate Management Handbook and maintain consistent regulatory standards
- Manage and maintain the e-CTD submission system
Requirements:
- PhD in Chemistry, Pharmacy, or a related field and good understanding of GMP guidelines
- Strong expertise in Regulatory Affairs (RA) and CMC development, with knowledge of both drug substances and products
- Minimum of 5 years of experience in a Regulatory Affairs role within drug substance or drug product areas
- At least 5 years of leadership or consulting experience in a regulated environment
- Proven experience in working with regulatory authorities and customers
- Excellent communication skills and the ability to work effectively in multicultural settings
- Strong English language skills, both written and verbal
- Flexible and willing to work overtime when necessary
- Strong decision-making abilities and a team-oriented leadership style
- Service-oriented mindset
Advantages with nemensis ag:
- Nemensis ag is your specialist recruitment partner in Life Sciences, based in Basel
- Comprehensive support and guidance throughout the application process from our consultants
- Access to a large client network and exciting job opportunities in Northwestern Switzerland
- Fast and easy entry with tailored support throughout the application process
Sounds like you? Don't hesitate, I look forward to your application!
About us
At nemensis ag, we have successfully connected thousands of candidates with their dream jobs, helping them advance their careers or re-enter the workforce. How can we help you and your career today? Reach out to us!
Contact:
Jannis Reis, Junior Consultant, E-Mail schreiben
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