Technical Regulatory Support Manager
vor 6 Monaten
**EINFÜHRUNG**:
As a preferred supplier for Roche in Basel, we are looking for an individual as
**Technical Regulatory Support Manager**:
with contract for 1 year. The earliest start date is within 2 months. Home Office will be possible for max. 2 days a week.
**AUFGABENBESCHREIBUNG**:
- 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
**ERFORDERLICHES PROFIL**:
- 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
***Application process**:
Interested? You can find more information here:
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