Senior Director, Global Regulatory Policy

Hiring By - Biostaffic

 BioPharma

Spain

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
The Senior Director of Global Regulatory Policy is responsible for driving EU regulatory policy development and advocacy, collaborating across Regulatory functions globally and with relevant business functions to align a single, integrated regulatory influencing strategy. The Senior Director will also be required to focus on specific policy topics according to business needs and will provide a broad strategic view for regulatory policy issues based on an in-depth knowledge of the internal and external regulatory environment.
The Senior Director will be a major participant articulating AZ’s consolidated view on key regulatory guidance and regulations. This includes developing and maintaining external relationships and being able to influence proposed rules and regulations that specifically impact AZ and ultimately the pharmaceutical industry.
Typical Accountabilities:
Monitor and Interpret the Regulatory Environment
  • Work collaboratively with other policy/intelligence groups to optimize horizon scanning
  • Coordinate collection and use of internal and externally gathered metrics to support policy strategies
  • Identify issues that require position/policy statements
  • Lead and/or support authoring of position papers on assigned topics
  • Ensure key risks are captured, robust mitigation plans are in place, and potential impact is communicated effectively to relevant parts of the business
Engage Internally
  • Build internal networks on complex topics impacting regulatory
  • Create and manage overall internal engagement strategy
  • Review relevant Calls for Comments to ensure they are complete, consistent, and appropriate
  • Manage relationship with senior management in policy and non-policy groups including AZ marketing companies
Engage Externally
  • Represent and advocate on behalf of AZ on broader external networks that address multiple topics
  • Represent company on external network for multiple and cross-functional topics and/brief senior management in advance of key external meetings
  • Identify and prioritize external engagement and monitoring topics
  • Actively engage key HA and trade organisation officials on matters that impact AZ business policy and practices
  • Provide a broad strategic view for regulatory policy and intelligence issues that form the basis of external engagement activities
  • Chair multiple topic external networks/committees, as appropriate
  • Develop networks with external senior Regulatory staff
  • Facilitate Senior Management engagement with Heads of Regulatory Agencies globally and other relevant governmental bodies
Other Accountabilities:
  • Focus on specific, globally impacting policy topics according to business needs and will provide a broad strategic view for regulatory policy issues based on an in-depth knowledge of the internal and external regulatory environment.
Essential Education, Qualifications, Skills and Experience:
  • Experienced Regulatory Professional with degree in a scientific/public policy/legal discipline.
  • Demonstrated ability of proactively shaping of the future regulatory framework through active membership on professional societies or trade organizations.
  • Comprehensive understanding of drug development processes
  • Understanding of AZ focused disease areas
  • Direct line or matrix management experience
Desirable Education, Qualifications, Skills and Experience:
  • Significant Regulatory Experience across global projects and regions
  • Strong commercial awareness
  • Problem solving skills
  • Focus on delivery and results
  • Excellent strategic influencing and negotiation
  • Develops collaborative working relationships
Key Relationships to reach solutions:
Internal:
  • AZ Regulatory functions, including Regulatory TA VPs, Regulatory Executive Directors, Global Regulatory Leads and Marketing Company Regulatory staff
  • Corporate & Government Affairs
  • Legal, Medical and Commercial staff
External:
  • External Trade Association members
  • Health Authorities
  • Relevant external networks and forum

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Spain

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 16, 2024
Company Overview
AstraZeneca
AstraZeneca

Current Openings: 0

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