Process & Procedures Regional Lead, Associate Director

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Job description

The Process & Procedures (P&P) Regional Lead, Associate Director is responsible for managing and supporting the analysis and interpretation of global and country specific functional business regulatory requirements and industry best practices to support the delivery of controlled procedural documents. The P&P Regional Lead will provide procedural expertise and work cross-functionally with regional and global teams directly with PPL leadership and along with functional leaders to identify, scope and plan projects mapped to business/ functional needs, and other strategic initiatives. Additionally, this role will serve as the DSOE point of contact to drive shared services initiatives that support organizational alignment

In this role, a typical day might include:

• Strategic Alignment/ Process Development
  • Understand the functional drivers and associated cross-functional processes and procedures within the assigned functional areas and in collaboration with senior stakeholders identify the need for new or updated procedural documentation.
  • Actively collaborate with functional stakeholders/process owners, to manage identified process gaps and ensure timely and effective remediation aligned with current policies, regulations, and business practices to ensure compliance.
  • Work with stakeholders in assigned functional areas to review ongoing and forecasted work and ensure priorities are aligned with GDs global strategic goals and objectives.
  • Responsible for reporting of metrics and risk escalation to drive compliance.

• Relationship Management

  • Establish, strengthen, and sustain key relationships within assigned functional areas to understand and forecast business needs, priorities, and challenges.
  • Drive cross-functional alignment to resolve discrepancies and enhance procedural effectiveness.
  • Act as the primary contact for all assigned functional areas.
  • Work internally within P&P to support cross-functional deliverables and metric reporting.

• Procedural Support and Consulting

  • Accountable for timely delivery of, high quality procedural documents and performance tools across assigned functional areas by collaborating with process owners, procedural documentation writers, quality managers and coordinators.
  • Ensure procedural documents are current and aligned with the P&P content standards.
  • Ensure document scope is maintained, communicating any risks or issues as appropriate.
  • Day-to-day tactical and operational management/oversight of procedural development

• Continuous Improvement

  • Identify and implement Continuous Improvement activities related to procedural document lifecycle including Quality by Design Identify, prioritize and manage deliverables and timelines to support procedural revisions and content development related to continuous improvement activities.
  • Identify, prioritize and manage deliverables and timelines to support procedural revisions and content development related to continuous improvement activities.

• Regional

  • End to End planning and support GD, Regional members and Enterprise business lines for process and shared services (eg. IOPS, commercial, G&A)
  • Workplace support for onboarding and ways of working to enhance effectiveness including cross-cultural program support aligned with the REGN way
  • Proactive identification, triage and implementation of regional process and procedure needs as it pertains to Global Development support across all impacted functions such as Clinical, Regulatory, Medical Affairs, Quality and Pharmacovigilance
  • Collaboration with global and regional leadership to align requirements and solve for complex challenges
  • As regional Shared Services lead, support implementation of global strategic initiatives

This role might be for you if have:

• Proven ability to work effectively across multiple stakeholders, with competing priorities.
• Effective communicator (written and oral)
• Ability to work independently and influence across, up and down the organization and manage multiple complex responsibilities and priorities.
• Experience in working in or with Clinical Trial Management, Regulatory, Pharmacovigilance and Risk Management
• Strong leadership skills with demonstrated ability to interface with Senior Leaders and navigate through complex situations.
• Experience in procedural document principles, process design, and leading process improvements is required.
• Client Focused and attention to detail with demonstrated organizational and emotional intelligence/awareness.
• Ability to plan, manage and optimize resources across a matrixed organization with multiple projects.
• Strong knowledge of Pharmacovigilance, Medical Affairs, Clinical GCP, and country specific Regulatory requirements
• Ability to think critically, strategically and operationally.

To be considered for this opportunity, we require a Master's degree and 8 years of experience or 10 years of experience with Bachelors within the life science industry. We also expect you to display the following competencies: Leadership, Stakeholder Management, Project Management, Process Development and Management, Strategic Thinking, Critical Thinking & Problem Solving, Integrity and Trust, Negotiating, Organizational & Political Savvy, Dealing with Ambiguity & Paradox. We also require you to be onsite three days a week at a minimum.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$151,800.00 - $247,800.00

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