For our customer located in Basel/Switzerland we are currently looking for a: Technical Regulatory Support Manager (m/f/d)
- latest Start Date: 01.01.2024
- Homeoffice: max. 2 days a week
- Extension: not possible for now
The perfect candidate:
The perfect candidate has a degree within life sciences or regulatory affairs and has collected first hands-on experience in technical regulatory affairs, with profound knowledge on national and international regulations. Storing project management skills as well as an affinity for IT tools are key to this role.
Tasks & Responsibilities
- Proactively support the technical regulatory department on the execution of submission-related and administrative activities for global technical registrations
- Effectively manage regulatory changes throughout the product life cycle
- Be responsible for preparation and maintenance of CMC documentation in internal document management systems as well as support associate activities
- Represent PTR on other cross-functional teams, advise cross-functional teams concerning regulatory requirements and work with diverse partners and personalities
- Ensure regulatory compliance together with local and global technical functions as well as assess technical change records for regulatory impact
- Contribute to excellence by finding opportunities, mitigating risks and supporting continuous improvement
- Contribute to driving efficiency by assertively simplifying, trying new ways and cutting out waste
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections
- Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
- Monitors and improves tracking/control systems
- Keeps abreast of regulatory procedures and changes
- Direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
Must Haves
- Must have a Bachelor’s degree – preferably in a scientific field; an advanced degree is a plus
- First hands on experiences ideally in technical regulatory affairs, with profound knowledge on national and international regulations and biotechnology
- Ability to manage projects and have excellent communication skills in English, German is a plus
- Ability to work with IT systems and have a high sense of responsibility concerning CMC data management
- Ability to work in interdisciplinary teams, global project teams and with several interfaces
- Ability to work in a diverse and changing, global environment as a positive challenge with multiple opportunities.
- Strong communication skills, ability to work in a team, proactivity and flexibility
- Ability to prioritize and work effectively both within a team environment and independently
- Ability to be open, curious and willing to experiment with New Ways of Working
- You are comfortable with taking risks, experimentation and ambiguity
- You take ownership, are decisive, and use your knowledge, network and creativity to solve problems and progress programs and projects
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.