Senior Regulatory Program Director (m/w/d) am Standort Mannheim
Senior Regulatory Program Director (m/w/d) am Standort Mannheim
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Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
Who are we:
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
Thats what makes us Roche.
The Opportunity:
In Pharma Technical Operations the manufacturing sites responsible for making our life saving medicines are the reason we exist. As the Technical Regulatory Site Strategic Partner (SSP) you as a senior Regulatory Professional will have the unique opportunity to integrate into the site Quality leadership team as a critical partner providing regulatory expertise to drive for comprehensive efficient decision making; ensure our right to operate; and ultimately deliver uninterrupted supply to patients.
Job Facts:
Overall responsibility and accountability for the quality efficiency and effectiveness of regulatory guidance for their assigned site
Ensuring crossfunctional PTR deliverables are completed compliantly accurately thoroughly and in a high quality and timely manner.
Contributing to regulatory excellence by identifying opportunities mitigating risks and supporting continuous improvement.
Understands the structure key roles and responsibilities of local and international regulators; understands global health authority regulations and ICH guidelines for excellence in regulatory compliance throughout product lifecycle
Support crossfunctional compliance processes to maintain right to operate
Staying abreast of HA trends line of questioning from regulatory filing and site Health Authorities inspections making the connection between the two for regulatory and assigned site and sharing this information with regulatory and with the site
Who are you:
Bachelors degree in a scientific discipline plus relevant experience; advanced degree highly desirable
Confirmed experience in the core activities of Technical Operations Quality and/or Regulatory with demonstrated experience with core regulatory CMC processes.
Extensive experience and proven success with influencing up across and down and with multidisciplinary teams and external experts
Strong knowledge of the regulatory environment including interactions with Health Authorities and ability to identify and address regulatory risks for your assigned site.
Ability to lead handle and communicate sophisticated CMC issues concisely and efficiently
You are able to speak the local language of the Mannheim site
Travel:
Ability to travel according to the needs of the position; domestic and international travel
Relocation:
We are not looking for a candidate that requires relocation but will consider a rare exception for an outstanding exceptional candidate.
Your contact to us! With people. For people.
Do you need further support
Required Experience:
Director
Employment Type
Full-Time
