Description
For one of our clients, I am looking a REGULATORY AFFAIRS CMC Manager with a sound global background.Tasks:
- provide strategic leadership and regulatory decision making for synthetic marketed products
- manage the generation of high quality regulatory submissions required for the filing of technical changes to health authorities globally
- close interactions with stakeholders from various technical functions like production, quality management and planning, both in headquarters and production sites
- CMC changes assessment and follow up
assess priorities on multiple projects
- global submissions
- answer to authority requests/solve deficiencies
- facilitate the effective and rapid implementation of technical changes
- ability to successfully negotiate with affiliates and authorities
Requirements:
- strong science or technical background in addition to practical regulatory experience
- advanced science degree (Master or PhD) or equivalent in chemistry or pharmacy
- ideally at least 5 years experience in small molecule drug development, manufacturing or quality management
- experience related to the preparation of regulatory applications (NDAs and / or post-approval submissions), planning of regulatory strategies, assessing regulatory compliance and supporting quality systems
- Excellent English skills / German desirable
- ability to work with multi-disciplinary teams and external experts as well as communication, problem solving and decision making skills
Start: ASAP
Length: 12 months
Volume of work: flexible (at least 60%)
Location: Basel (on site) + remote (tbd)
If you are interested, feel free to contact me right away.