English English

Regulatory Affairs Senior Specialist

   United States |  Full time

Apply Now

Posting Date :  2020-11-09

Job Identification :  10706

Department  :  Regulatory Affairs

Please note that this role can be located in the United States or Canada and will require travel to our sites in California, Illinois, Minnesota and Cambridge, Ontario (Canada) as well as international travel. Reporting into the North America Director of Regulatory Affairs 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.
  • 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. Responsible for providing sound input and regulatory strategy with regards to specifications, certificates of analysis, rejections, impurities, manufacturing site details and drug master file/veterinary master files.
  • 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. 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.
  • Interface/coordinate with API Vendors regarding Type II Drug Master Files and Veterinary Master Files in the context of approvability for use in Bimeda finished products. Assessment of Master File submission readiness, acceptability of reported changes and annual updates. Assist API Vendors in overcoming approval issues as necessary. Support for facility audits to ensure compliance with Regulatory requirements.
  • 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.
  • Coordination and support for applications for EU Certificate of Suitability (CEP) connected to Marketing Authorizations, also European Drug Master Files (EDMF).
  • 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. Identification/vetting of potential suppliers, arrangement of sampling and testing requirements, and subsequent documentation for implementation of the materials at the manufacturing site level.
  • Preparation and review of technical documents as needed to support NPD and PLCM (e.g. residual solvent statements, SDS).
  • Manage supplier information database to allow for compliant Regulatory submissions, a clear picture of existing and potential suppliers, and effective decision making.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Other 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, Bio-chemistry, 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, Bio-chemistry, 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.

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

Your application to us; assumes you have read and agree with our privacy policy

More Info at www.bimedacareers.com

 

About Us

Bimeda is a leading global manufacturer,  marketer and distributor of animal health products and veterinary pharmaceuticals.  Through ongoing expansion and strategic acquisition,  Bimeda has established markets in more than seventy countries worldwide and has R&D,  manufacturing and distribution capabilities across Europe,  North America,  South America,  Africa,  Asia and Australasia.


global

OPERATES
IN OVER
75
countries

people

800+
EMPLOYEES

lab

6
R&D and
REGULATORY
LABS

factory

9
MANUFACTURING
facilities in
7 COUNTRIES