Planet Pharma
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Target PR Range: 26-36/hr
*Depending on experience
Job Summary:
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 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
*CO/NYC candidates might not be considered
Regulatory Affairs Senior Associate
Posted: 12/03/2024
2024-12-03
2025-01-04
Employment Type:
Contract
Job Category: Regulatory Sciences and Medical Writing
Job Number: 615786
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 26-36/hr
*Depending on experience
Job Summary:
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 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
*CO/NYC candidates might not be considered
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