Regulatory Global Process Owner

9 hours ago

London, Greater London, United Kingdom VONQ Full time
Job Description

Regulatory Global Process Owner

VONQ is seeking a highly skilled Regulatory Global Process Owner to join our team. As a key member of our organization, you will be responsible for developing, maintaining, and monitoring regulatory processes in accordance with global regulatory requirements and industry standards.

Key Responsibilities:

  • Develop and maintain GRA owned processes, their strategic direction, and continuous improvement.
  • Ensure assigned processes are compliant with global legal/regulatory requirements and industry standards; actively monitor compliance with existing or newly initiated processes across products and regions.
  • Design and implement key performance indicators (KPI) to monitor performance of improved processes and measure results; collaborate with Regulatory peers, Senior leaders, and Quality Leads to develop in-process controls and management monitoring strategies for assigned processes.
  • Lead/input to Risk and Issue Management activities, designing/agreeing appropriate mitigations.
  • Lead & enable process improvement initiatives, drive innovation in continuous improvement programs to deliver streamlined, efficient processes.
  • Maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, and industry standards pertaining to the assigned processes.
  • Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection and provide expert advice on responses to audit observations; be point of contact and interact with inspectors to support audits as appropriate.
  • Build a strong network of stakeholders and SMEs across VONQ to support and influence cross-functionally. Providing oversight and direction to any matrix assigned Regulatory Process Leads as required.

Why You?

We are looking for professionals with the following required skills to achieve our goals:

  • Has extensive experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, including applicable Regulatory requirements.
  • Ability to operate with independence effectively communicating at all levels within VONQ and within or leading a team to ensure on-time delivery of objectives/projects.
  • Has an end-to-end enterprise mindset with the ability to break down silos within and across the organization to be able to offer maximum benefit to our users and VONQ as a whole.
  • Experience working within a complex IT System Landscape within a regulated environment.
  • Team/Matrix team leadership experience with the ability to manage and motivate people effectively through change.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • A proven capability as a leader with a global mindset.
  • A flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, and drives change where appropriate. Challenges and questions ways of working to seek improved processes.
  • Establishes team goals and uses these to seek improved performance; sets challenging but realistic targets.
  • Able to think creatively to source information relating to role and the interaction with the broader regulatory function.
  • Excellent communication skills both oral and written. Proven ability to communicate with clarity, impact, and passion.
  • Proven track record in promoting and delivering innovation.
  • Proven ability to build high-performing global matrix team relationships.
  • A strong sense of urgency, able to effectively prioritize such that key issues or emerging high-priority matters are handled in a timely and effective way.

What We Offer:

VONQ offers a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings program. We also offer a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Why VONQ?

VONQ is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Equal Opportunities Employer:

VONQ is an Equal Opportunity Employer, and we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, color, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.*

Agile Working Culture:

VONQ believes in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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