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Regulatory Affairs Senior Specialist

  Chicago, IL,  United States |  Full time

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Posting Date :  2021-12-22

Job Identification :  10939

Department  :  No Category

This role is responsible for Regulatory Affairs aspects of new product development (NPD) and product life cycle management (PLCM) related to sourcing and maintenance of active pharmaceutical ingredients (APIs) and formulation excipients in connection with Quality and Supply Chain. The role also provides support for material import and export activities. The Regulatory Affairs Senior Specialist builds and maintains strong relationships with agents and manufacturers to assist in ensuring optimal supply of materials/APIs from a compliance (cGMP and Regulatory) standpoint.

Key Responsibilities:

  • Liaise and work directly with the appropriate functional groups within Bimeda and external manufacturers on technical, quality, and regulatory topics related to active pharmaceutical ingredients (APIs) and excipients. Understanding of analytical chemistry and in particular chromatography, impurities, residual solvents, etc.
  • Support Supply Chain in efforts to secure API supply and maintain multiple options for key actives.  Assist Supply Chain and Quality in regard to supplier complaints, technical investigations and follow up with supplier partners. Maintain awareness of cost and inventory considerations in relation to API and excipient supply.
  •  Maintain current knowledge of regulatory requirements and industry trends by continued review of regulations, new guidelines, and trade publications. Understanding of domestic Type II veterinary master file/drug master file requirements. Participation in working groups of trade associations such as Generic Animal Drug Alliance and industry events such as CPHI.
  • Facilitate assessments of Type II DMF/VMF in the context of approvability for use by Bimeda. Consult as necessary on registration and facility audit matters.
  • Provide regulatory import/export strategies for Bimeda products, including export dossiers. Review, edit and submit regulatory documents and export certificates for foreign facilities. Routine monitoring of relevant API facility GMP status and import alert issues.  Assist in API, excipient and Bimeda product import/export issues that can arise at US ports.
  • Interface with supplier agents, manufacturers and Bimeda colleagues to obtain Quality Agreements, cGMP evidence and other documentation necessary for compliant Health Canada Table A submissions and maintenance.
  • Act as or on behalf of Bimeda US Agent and liaise with FDA on behalf of API Manufacturer organizations to facilitate regulatory review of submissions.
  • Support R&D pipeline activities in relation to API and excipient needs for NPD. Vetting of potential suppliers, arrangement of sampling and testing requirements, and subsequent documentation for implementation of the materials at the manufacturing site level.

Requirements:

Essential:

Experience

  • 3 years minimum pharmaceutical industry experience.
  • 2 years minimum regulatory submission experience.
  • 2-3 years development, interpretation or application experience with standards, guidelines and special controls.
  • Working knowledge of Supply Chain (including import/export) for pharmaceuticals.

Education

  • BA/BS in technical field or scientific discipline (Biology, Biochemistry, Chemistry) is required.

Technical

  • Experience with Microsoft Office Suite programs.

Other

  • Good written and verbal communication skills are required.
  • Good organizational and troubleshooting skills are required.
  • Self-motivated and committed to a team approach.
  • Strong interpersonal and organizational skills.
  • English as first language.

Desirable:

Experience

  • 5 years pharmaceutical industry experience.
  • Project Management experience.
  • 3 years US FDA/CVM CMC submission experience.
  • Strong working knowledge of FDA regulations and requirements with the ability to integrate into projects.
  • Strong technical writing and editing skills.

Education

  • Advanced degree (e.g. MS, PhD, PharmD) in Biology, Biochemistry, or Chemistry is preferred.

Technical

  • Experience with SharePoint or other information management programming. Project management software experience. Experience with ESubmitter software and FDA Webtrader.

Other

  • Should possess a well-defined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills.
  • Able to build and maintain lasting relationships with corporate departments and key business partners.

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