Regulatory Affairs Associate

Role Summary

This role is responsible for Regulatory Affairs aspects of product life cycle management (PLCM) related to post approval

submissions and drug product registrations. The Regulatory Affairs Associate builds and maintains strong relationships

with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint.

Key Role Specific Requirements

• Manage regulatory maintenance activities for approved NADA and ANADA products.
• Maintain approved NADA and ANADA applications throughout the product lifecycle.
• Compile and submit:

• • Annual reports
  • CMC submissions
  • Labeling supplements
  • Correspondence with regulatory agencies

• Maintain regulatory records submission archives commitments and approval histories.
• Ensure compliance with applicable regulations guidance documents and approved filings.
• Maintain awareness of evolving FDA and industry requirements through ongoing review of regulations
• guidance documents and industry publications.
• Cross-functional communication and data gathering on GMP documentation required for post-approval
• submissions for US marketed products.
• Coordination of appropriate communications and maintenance of state registrations for drug product
• distribution.
• Proficiency in electronic submissions to FDA-CVM.
• Perform regulatory reviews and assessment of cGMP documentation. Determine appropriate reporting
• categories per FDA regulations.
  

Competencies Required for the Role

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a

situation seek that information from various sources and then tackle a problem by using a logical systematic

sequential approach. Ability to identify and separate the key components of problems and situations. Ability

to interpret information from a range of sources to spot patterns and trends in information and to deduce

cause and effect from this

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently to

listen help facilitate sharing of information between people. It is about understanding the emotional

intention behind the information. The ability to express oneself clearly in conversations confirm

understanding communicate using data and facts whilst adapting to ones audience. Exhibit willingness to

listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal

and business writing.

INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires

it.

PLANNING is the process of thinking about and organizing the activities required to achieve a desired goal.

AMBITION Demonstrates desire and dedication to achieve goals; effort to achieve a higher desired state

position or goal through a series of deliberate actions (education self-improvement reading mentoring

stretch assignments etc.); is determined to succeed; surpasses their own expectations; focuses on personal

development.

Essential

• Minimum of two (2) years of experience working in a professional office or laboratory environment with
• responsibility for managing documents records and multiple concurrent priorities.
• Proficiency in Microsoft 365 applications (Word Excel PowerPoint Teams and Outlook) and the ability to
• learn and effectively utilize digital regulatory document management and AI-enabled productivity tools.
• Experience using Adobe Acrobat Pro Foxit PDF Editor or similar document management software.
• Strong written and verbal communication skills.
• Excellent organizational skills with a high degree of accuracy and attention to detail.
• Demonstrated ability to work independently prioritize tasks and manage multiple responsibilities effectively.
• Self-motivated with a collaborative team-oriented approach.
• Eagerness to learn and develop new skills.
• Ability and willingness to travel occasionally (approximately 2%).
  
  

Desirable

• Minimum of two (2) years ofexperience in regulatoryaffairs the pharmaceutical industry or a similarlyregulated environment.
• Associates Bachelors or equivalent post-secondary degree in a related field.
• Experience with FDA electronic submission systems including eSubmitter and FDA ESG NextGen.
  
• Experience with SharePoint electronic document management systems (EDMS) information management platforms and project management software.
  
• Experience or demonstrated skills in project coordination problem solving regulatory submissions and or exposure to manufacturing environments.
  
• Understanding use of AI tools such as Microsoft Copilot ChatGPT or other similar platforms.
  
• Experience supporting document preparation submission activities or regulatory records management within a regulated industry.
  
• Knowledge of continuous improvement principles regulatory monitoring activities and regulatory risk identification.
  
• Able to build and maintain lasting relationships with cross functional team members.
  

What We Offer

• Health Insurance (medical dental vision)
  
• 401(k) plan for retirement savings
  
• Paid time off (vacation sick leave holidays)
  
• Life insurance
  
• Employee assistance program
  

About Bimeda
Bimeda is a leading global innovator manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a centurys experience in providing science-driven solutions to optimize the health wellbeing and productivity of the worlds animals.

Bimedas global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimedas 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 commercialization 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.

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Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race color religion gender gender identity or expression sexual orientation national origin genetics disability age or veteran status.

Required Experience:

Junior IC