|| Associate, Regulatory Affairs
The Associate, Regulatory Affairs supports the Regulatory Affairs team in day-to-day activities to ensure the timely compilation and submission of INDs, NDAs, ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA.
- Review technical/regulatory/clinical documentation related to INDs, NDAs, ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements, and annual reports.
- Author and compile supplements/amendments to support department goals and meet FDA timelines.
- Prepare electronic files for inclusion in eCTD submissions, per the applicable guidelines.
- Evaluate proposed changes to applications versus current available guidance documents and formulate filing strategies and filing requirements.
- Prepare and submit Annual Reports and PADERS in accordance with the established schedule and per applicable guidelines.
- Create, revise, and maintain drug product labeling.
- Bachelor’s degree in a science (preferably Biology, Chemistry, Pharmacy).
- Minimum of 2 years of pharmaceutical industry experience.
- Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems;
- Ability to learn new technology and apply to business needs.
- Ability to read, analyze, and interpret scientific and technical Agency guidance. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the technology community.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- High degree of professionalism, ethics and integrity
- Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
- Willing to participate in our group identity characterized by commitment, trust, and care for each other.
- Willing to invest time and energy in continuous improvement efforts