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Regulatory Affiliate Manager
vor 3 Monaten
At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Regulatory Affiliate Manager (M/F/d)
Role Purpose:
Regulatory Affiliate Manager within Regulatory Affairs Life Cycle Management team part of the RMSC organization (Regulatory, Medical, Safety & Compliance) is to coordinate Affiliate Specialists and their activities across the different Therapeutic Areas.
Key Tasks and responsibilities:
- Coordinates Affiliate Specialists (AS) and their tasks across all Therapeutic Areas.
- Represents primary contact for AS related tasks for internal and external stakeholders.
- Schedules and leads AS meetings with the objective to share expertise, lessons learned and align on ways of working, monitors monthly overview of AS tasks.
- Ensures that established processes are followed by AS and the stakeholders; Proactively works on improvements, harmonization and standardization of the AS related processes, tasks, and responsibilities to ensure consistency and data integrity.
- Is responsible for onboarding of new AS, smooth transition of workload as necessary and facilitates during challenging situations with internal and external counterparts.
- Coordinates regulatory contributions for Safety Reports (PBRERs, ACOs, DSURs), primary contact point for RA processes, systems, internal and external counterparts in respect to RA contribution for safety
- Coordinates product renewals, site registrations, site renewals, GMP clearance renewals, import license updates & tender business, CMC documents to sites.
- Ensures harmonized way of creation and maintenance of regulatory documents & tasks by the AS related to new registrations, variations, site changes.
- Coordinates preparation and signing of RA submission relevant statements, performs review of RA administrative related invoices in the system.
- Represents AS in RA Process Simplification team (SOP Reviews).
- Represents AS in Regulatory Information Management System (RIM) project (post golive phase).
- Supports coordination of changes (API and Finished Good) in the Change Management System.
- Support Sampling team as necessary
- Enters Deviations for LCM team into the system as necessary
Who are you:
- University Degree in Life Sciences
- 3 to 5 years of experience in a role within the pharmaceutical/consumer health industry (Regulatory Affairs)
- Strong knowledge of regulatory procedures (European, ME, LATAM & Asia Pacific)
- Experience in project management, experience with leading teams
- Solution oriented with the ability to deliver ideas for change and continuous process improvement, while paying attention to details and consistent approach.
- Strong organizational skills with the ability to work focused and target oriented in a complex scientific/ technical environment and to work on multiple projects in parallel. Capability to organize and direct diverse activities in a changing environment, often under time pressure. Ability to absorb large amount of information efficiently, give sound judgements and act professionally to manage difficult situations effectively
- Ability to work effectively within a crossfunctional team and across hierarchical levels
- Networking and influencing skills, customer focus
- Effective and transparent communication style in English (verbal and written)
- Proficiency in MS Office: Word, Excel, PowerPoint
- Experience with RIM and Change Management systems, knowledge of database concepts
YOUR APPLICATION
Location:
Switzerland :
Basel-City : Basel
Division:
Consumer Health
Reference Code:
788769
