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 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. Your application to us; assumes you have read and agree with our privacy policy More Info at 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. #J-18808-Ljbffr Bimeda