Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate with a biopharmaceutical company located in North Chicago, IL.
- With manager support, manages/provides operational oversight to ensure timely, high quality regulatory submissions. Participate in the development of project plans using established templates.
- Plans and negotiates publishing timelines with the teams.
- Effectively manages multiple projects and competing priorities.
- Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.
- Plans and conducts submission team meetings.
- Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
- Participates in the development of optimal business processes and practices within the department to ensure high levels of customer support and to achieve high quality submissions.
- Demonstrates submission team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Some supervision of projects and assistance with priority setting requires.
- Receives project assignments from manager but has responsibility for managing own projects.
- Reviews project progress with manager on a regular basis with direction provided on follow-up.
- Identifies opportunities for process improvements. May participate on internal project teams to update business processes.
Skills and Requirements:
- Bachelor's degree.
- Years of experience may also compensate for lower education.
- 4 years pharmaceutical or industry related experience.
- Experience working in a complex and matrix environment
- Strong communication skills both oral and written.
- Preferred qualifications include PMP and RAC certificates, experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area, experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.