Regulatory Affairs Associate (Temporary) - United States
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Reporting to the Senior Manager, Regulatory Affairs CMC, you’ll be responsible for:
Coordinating the planning, preparation and submission of global regulatory CMC-related submissions, including post approval variations, Marketing Application(s) and Annual Reports.
Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time.
Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
Ensuring consistent and appropriate communication within the department and with other functional areas.
Interfacing with global Regulatory partners, internal cross functional teams, and consultants.
Assisting in the preparation for meetings with global regulatory authorities.
Attending relevant functional area and project team meetings.
- At least 2 years of experience in Regulatory Affairs or a related function such as Quality or Process Development in a global Pharmaceutical and/or Biotechnology Company (preferably with exposure to biologic products).
- Outstanding interpersonal and communication (written and verbal) skills is required.
- Strong writing and editing skills for technical documentation.
- Project management skills are a plus.
- Proficient with computer and standard software programs.
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.
- Advanced degree is a plus.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.