What are the responsibilities and job description for the Regulatory Affairs Associate II position at Planet Pharma?
Target PR Range: 30-40/hr
Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders.
Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s). May assist Enhancement Leads to triage and disposition enhancement requests.
Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
Update ongoing regulatory plans as necessary to align with improvements made to planning templates.
Support relevant complex and/or cross-functional initiatives as needed.
May lead or co-lead straightforward, departmental process improvement activities.
May be responsible for generating regulatory planning metrics, reports, and/or other system-related needs.
Assist in system-related training and/or updates to training material / logistics.
Required Experience
- depending on experience
Execute assignments that ensure complete and accurate regulatory planning information is readily available for leadership and cross-functional stakeholders.
Serve as a key member of the Regulatory Portfolio Management core team responsible for enhancing and maintaining the planning and reporting system(s). May assist Enhancement Leads to triage and disposition enhancement requests.
Partner with Regulatory Strategic Planning colleagues to capture large datasets and prevent backlogs.
Update ongoing regulatory plans as necessary to align with improvements made to planning templates.
Support relevant complex and/or cross-functional initiatives as needed.
May lead or co-lead straightforward, departmental process improvement activities.
May be responsible for generating regulatory planning metrics, reports, and/or other system-related needs.
Assist in system-related training and/or updates to training material / logistics.
Required Experience
- 2 years of pharmaceutical or industry-related experience
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- Experience / understanding / use of software tools
- Keen awareness of cultural nuances / Proven ability to work in a global environment
- Strong attention to detail and problem-solving skills
- Experience in Regulatory Affairs and/or Project Management preferred but may consider related area
- Understanding of global regulations