Job Description
Description:
Note: Remote
- 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"
Job Tags
Local area, Remote job,