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 willingn