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Regulatory Operations Coordinator
Regulatory Operations CoordinatorCencora • Oakland, CA, US
Regulatory Operations Coordinator

Regulatory Operations Coordinator

Cencora • Oakland, CA, US
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Regulatory Coordinator

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

This role is in support of Cencora's veterinary and livestock production solutions marketed through our MWI Animal Health business. MWI Animal Health is a leading brand of Cencora, offering animal health services globally.

Duties and Responsibilities :

  • Organize and support management review meetings in accordance with applicable SOPs
  • Work closely with subject matter experts to ensure suppliers meet quality expectations through audits, performance monitoring, and corrective actions when necessary
  • Negotiate and maintain quality agreements with suppliers and manufacturers for MWI's premium brands
  • Respond promptly to audit inspection inquiries by providing accurate information and supporting documentation
  • Work with the management teams to develop follow-up action plans for addressing any identified non-compliance issues
  • Review and manage the documentation on adverse events and quality complaint incidents
  • Provide quality input for investigations and support corrective and preventive action initiatives to address root causes
  • Organize regular reviews Standard Operating Procedures (SOPs) and Work Instructions (WIs) with process owners to these documents align with established service standards as well as quality and regulatory requirements
  • Verify adherence of MWI employees to all company policies and procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation
  • Ensure that MWI License(s) as well as any other regulatory documentation is up to date
  • Identify opportunities for process improvements through data analysis and continuous evaluation of existing workflows
  • Perform other duties as assigned.

Education and Experience :

  • Bachelor's degree preferred, in healthcare or science discipline or 2 years of professional experience in a healthcare setting or pharmaceutical company.
  • Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance.
  • Experience in auditing, risk management, and / or quality management
  • Knowledge of QMS software preferred.
  • Skills and Abilities :

  • Excellent oral and written communication skills.
  • Ability to effectively manage and participate in cross-functional problem-solving teams.
  • Excellent teamwork and people skills.
  • Ability to handle a variety of tasks simultaneously.
  • Excellent critical thinking skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
  • We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

    Salary Range

  • : $57,900 - 85,360
  • This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

    Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

    Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned.

    Affiliated Companies : Centaur Services

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