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Full-time
associate degree, bachelor degree
Health Insurance, 401(k) plan, Paid time off, Life insurance, Employee assistance program
Posted 6d ago
~40 hrs/week
Remote in Houston, Texas, United States
Responsibilities
Manage regulatory maintenance activities for approved NADA and ANADA products throughout their lifecycle. Ensure compliance with FDA regulations by compiling submissions, maintaining records, and coordinating cross-functional GMP documentation.
Requirements
Requires at least two years of experience in a professional office or laboratory environment with document management responsibilities. Proficiency in Microsoft 365 and document management software is essential, with a preference for experience in regulatory affairs or the pharmaceutical industry.
Full job description
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 one’s 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 of experience in regulatory affairs, the pharmaceutical industry, or a similarly regulated environment.
Associate's, Bachelor's, 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 century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s 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.
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 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.
Founded in Ireland in 1960, Bimeda is an international developer, manufacturer and marketer of veterinary pharmaceuticals and animal care products. In addition to distributing Bimeda branded products in over eighty countries world-wide, Bimeda also manufacture private label for distributors, agents and international companies.
Bimeda has 9 manufacturing facilities based in Ireland, the UK, Canada, the US, Brazil, and China. The company employees over 1,000 employees worldwide and has its global headquarters in Carrickmines, Dublin, Ireland. Bimeda's North American headquarters are in Schaumburg, Illinois.
To find out about career opportunities at Bimeda, visit bimedacareers.com
Offices: Broomhill Road, Tallaght, Dublin 24, IE · Bimeda Inc.,, One Tower Lane, Suite 2250,, Oakbrook Terrace,, Illinois 60181, US · 2 Bryn Cefni Industrial Park, Llangefni, Anglesey, Wales LL777XA, GB · Bimeda Brasil S.A., Rodovia Cônego, Cyriaco Scaranello Pires, 421, Distrito Industrial Caixa Postal 53, Monte Mor/SP 13190-000, BR · Funzi Rd (Off enterprise Road), Industrial Area, P.O. Box 30620-00100, Nairobi, KE
Founded in Ireland in 1960, Bimeda is an international developer, manufacturer and marketer of veterinary pharmaceuticals and animal care products. In addition to distributing Bimeda branded products in over eighty countries world-wide, Bimeda also manufacture private label for distributors, agents and international companies.
Bimeda has 9 manufacturing facilities based in Ireland, the UK, Canada, the US, Brazil, and China. The company employees over 1,000 employees worldwide and has its global headquarters in Carrickmines, Dublin, Ireland. Bimeda's North American headquarters are in Schaumburg, Illinois.
To find out about career opportunities at Bimeda, visit bimedacareers.com
Offices: Broomhill Road, Tallaght, Dublin 24, IE · Bimeda Inc.,, One Tower Lane, Suite 2250,, Oakbrook Terrace,, Illinois 60181, US · 2 Bryn Cefni Industrial Park, Llangefni, Anglesey, Wales LL777XA, GB · Bimeda Brasil S.A., Rodovia Cônego, Cyriaco Scaranello Pires, 421, Distrito Industrial Caixa Postal 53, Monte Mor/SP 13190-000, BR · Funzi Rd (Off enterprise Road), Industrial Area, P.O. Box 30620-00100, Nairobi, KE