The ideal candidate for this role is an entry-level professional with strong communication skills, adept at understanding and conveying scientific information, and comfortable with ambiguity.
They should have a bachelor’s degree with at least two years of experience or a master’s degree, preferably in a science or engineering field.
Familiarity with Office 365 is essential, and while experience in FDA-regulated or biotech/pharma industries is preferred, candidates from other regulated sectors will also be considered if they have relevant education.
This position is primarily administrative, focusing on documentation coordination under managerial oversight.
Description:
In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
To coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements.
To manage and execute of the preparation, delivery and electronic archiving of documentation for inclusion in US regulatory submissions
To assist the Global Regulatory Lead to manage GRT interactions
The responsibilities of the Regulatory Affairs Senior Associate position are:
Assist US Regulatory Lead to support regional regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with Regional Regulatory Lead
Create and maintain product regulatory history documents through Amgen systems and appropriately archive all regulatory documents and agency communications
Review regional component of the Global Regulatory Plan and provide input to operational deliverables
Collaborate with CRO’s / partners to support site initiation
Coordinate collection of functional documents in support of regulatory filings
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports,
investigator packages)
Prepare regulatory packages and cross-reference letters to support investigator initiated studies
Complete regulatory forms to support agency communications
Provide regulatory support through cross-functional interactions in work package teams (eg. commercial and evidence generation teams)
Support process improvement initiatives, standards development, and metrics
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Develop Regulatory Position with GRT
Actively support regulatory compliance
Support the development and execution of GRT goals
Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Top 3 Must Have Skill Sets:
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to deal with ambiguity
Pay Rate- between $35 - $40/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"