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Director of Chemical and Biological Regulatory Affairs

72% Flex
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor's or Master's Degree, Minimum 5 years of leading projects or teams, familiar with Agilent products and markets served.

Key responsabilities:

  • Establish regulatory strategies for global product registrations and innovation support
  • Develop and implement programs ensuring products meet chemical and biological regulations
  • Manage regulatory inspections, departmental resources, budgets, and lead talent development
  • Represent the company in regulatory meetings, embrace a customer-centered culture
Agilent Technologies logo
Agilent Technologies Biotech: Biology + Technology XLarge https://www.agilent.com/
10001 Employees
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Job description

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Your missions

Job Description

Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization.  You will lead a global team of regulatory professionals to establish business strategies providing regulatory guidance and input to ensure Agilent’s chemical and biological products are designed and manufactured to be compliant with national, regional, and global chemical and biological regulatory requirements.  You will lead the execution of regulatory responsibilities, in accordance with global regulatory policy and processes, and ensure chemical and biological regulatory support across all divisions within Agilent.  You will also be a member of the GRA leadership team and will periodically travel to ensure the delivery of business objectives.

Role Expectations

  • Establish and execute a vision for the Chemical and Biological Regulatory Affairs function, including the optimization of an organizational structure to enhance efficiencies and enable professional development of chemical/biological regulatory personnel.

  • Establish regulatory strategies with the goal to maximize successful, expedient, and compliant product registrations in worldwide jurisdictions.  You will partner with commercial leaders to define regulatory strategies that support new market access objectives and the launch of new product innovations.

  • Lead and develop a team of regulatory affairs professionals in areas such as HazCom management, product stewardship, new product development support, labeling reviews, and lifecycle support activities.

  • Develop and implement programs and processes to ensure that Agilent products are safe, legal, and meet or exceed customer expectations for chemical and biological regulatory compliance.

  • Represent the organization at regulatory and business meetings as both an expert and strategic business leader.

  • Acts as a change agent to help establish a customer-centered culture.

  • Provides expertise in translating regulatory requirements into practical, workable plans.

  • Partners with other functions, such as Global Trade, to develop and implement country-specific strategies for Agilent’s Chemical/Biological Product Regulatory organizational capabilities.

  • Represents the company in industry associations and standards bodies and may interact with regulatory agencies.

  • Lead a team of regulatory affairs professionals, with a focus on talent development, employee engagement, and leading diversity, equity, and inclusion.

  • Provide guidance relative to managing regulatory inspections and appropriately responding to any inquiries/observations.

  • Actively lead departmental resources and budget to meet strategic goals.

  • Manages work groups representing multiple processes, regions, and business regulatory programs.

  • Assists in the creation and execution of Agilent’s overall Global Regulatory Affairs strategy and manages and develops regulatory affairs talent within the Global Regulatory Affairs organization.

Qualifications
  • Bachelor’s or Master’s Degree or equivalent.

  • Broad knowledge of functional area(s) of responsibility.

  • Minimum of 5 years of experience formally or informally leading people, projects and/or programs.

  • Familiarity with the markets Agilent serves, Agilent products and customers’ business needs.

  • Experience driving global, transformational initiatives to include establishing effective operating models for regulatory organizations.

  • Demonstrated track record of results using interpersonal, relationship-building skills required to lead multi-cultural and geographically dispersed teams in a fast-paced, highly matrixed environment.


Personal Characteristics

  • Transformational leader who brings intensity & excitement everyday.

  • Passionate, visionary thinker with a desire to excel and inspire others.

  • High degree of self-awareness and emotional intelligence.

  • Creative thinker willing to explore unique, out-of-the-box solutions.

  • Persistent in the face of resistance and adaptable to rapid change.

  • Ability to weave complex concepts into a clear, compelling message.

  • Excellent collaboration, influencing, and facilitations skills across business groups, functions, and employee levels.

  • Pragmatic and customer focused.

  • Ability to identify and focus on key priorities.

  • Self-starter, self-reliant, courage, and conviction.

  • Willingness to engage teams and business partners across multiple time zones.

  • Experience with Enterprise Compliance Software Solutions.

#LI-PK1

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Option to Work Remote
Yes

Travel Required
Occasional

Shift
Day

Duration
No End Date

Job Function
Quality/Regulatory

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Soft Skills

  • Leadership
  • Strategic Decision Making
  • Interpersonal Skills
  • Emotional Intelligence
  • Adaptability
  • Team Collaboration
  • Problem Solving

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