Intermediate (2-5 years of experience)
Summary of the Role
The Regulatory Affairs Associate will be responsible for ensuring that the company's products comply with all regulations and laws pertaining to their development, manufacture, and distribution. The role involves coordinating submissions to regulatory agencies, reviewing product changes for impact on regulatory filings, and maintaining regulatory documentation.
Required Skills
Strong organizational and communication skills.
Ability to work effectively in a team environment and interact with all levels of management.
Strong analytical and problem-solving abilities.
Proficiency with electronic submission software and document management systems.
Familiarity with GxP (Good Practice) requirements.
Excellent writing skills for the preparation of regulatory documents.
Qualifications
A bachelor's degree in life sciences, pharmacy, or a related field.
At least 2 years of experience in regulatory affairs or a related field.
Knowledge of FDA, EMA, and other regulatory body's guidelines and regulations.
Experience with regulatory submissions and knowledge of submission formats (e.g., NDA, ANDA, BLA, 510(k), PMA).
Proven ability to manage multiple projects at once while paying strict attention to detail.
Responsibilities
Prepare and submit regulatory submissions to obtain and maintain approvals for product marketing.
Ensure compliance with regulatory agency regulations and interpretations.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Analyze product changes for impact on regulatory filings worldwide.
Communicate with regulatory and government agencies regarding pre-submission strategies, potential regulatory pathways, and compliance test requirements.
Participate in internal audits and inspections.
Maintain an up-to-date understanding of laws, regulations, and guidelines, interpreting regulatory rules or rule changes and ensuring that they are communicated through corporate policies and procedures.