Senior Regulatory Program Director (m/w/d) am Standort Mannheim

F. Hoffmann-La Roche Gruppe; Mannheim; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Regulatory Professional to join their Pharma Technical Operations team. This pivotal role involves integrating into the site Quality leadership team, ensuring compliance with regulatory standards, and contributing to the continuous improvement of processes. The ideal candidate will possess a strong background in regulatory compliance and technical operations, with the ability to influence cross-functional teams effectively. This is a unique opportunity to make a significant impact on the delivery of life-saving medicines, all while thriving in a supportive and innovative environment.

Qualifikationen

• Bachelor’s degree in a scientific discipline plus relevant experience.
• Confirmed experience in Technical Operations and Regulatory activities.

Aufgaben

• Overall responsibility for regulatory guidance at the assigned site.
• Ensure compliance with regulatory deliverables and continuous improvement.

Kenntnisse

Regulatory Compliance

Technical Operations

Quality Assurance

Cross-functional Team Leadership

CMC Processes

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree

Jobbeschreibung

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.

Your contact to us! With people. For people.

Do you need further support?

Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.