You oversee the quality of regulatory guidance, ensure compliance, and support continuous improvement. This role involves staying updated on health authority trends and effectively coordinating cross-functional compliance efforts.
Anforderungen
- •Bachelor’s degree in a scientific discipline
- •Advanced degree highly desirable
- •Confirmed experience in Technical Operations
- •Demonstrated experience with regulatory CMC processes
- •Extensive experience influencing multi-disciplinary teams
- •Strong knowledge of regulatory environment
- •Ability to identify and address regulatory risks
- •Ability to lead and communicate sophisticated CMC issues
- •Ability to speak the local language of Mannheim
- •Ability to travel according to position needs
- •Domestic and international travel
- •No relocation required, rare exception considered
Deine Aufgaben
- •Ensure quality and effectiveness of regulatory guidance.
- •Complete cross-functional PTR deliverables compliantly.
- •Identify opportunities and mitigate risks for regulatory excellence.
- •Understand global and local regulatory structures and guidelines.
- •Support compliance processes to maintain operational rights.
- •Stay updated on health authority trends and inspection topics.
Original Beschreibung
# Senior Regulatory Program Director (m/w/d) am Standort Mannheim
**Mannheim** | **Full time**
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. It’s 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.**
**That’s 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 cross-functional 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 cross-functional 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:***
* **Bachelor’s 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 multi-disciplinary 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.**
**Roche is an Equal Opportunity Employer.**