Job Description:

Location: REMOTE

Salary: $35.00 USD Hourly - $39.00 USD Hourly

Description:

Position Title: Associate Regulatory Affairs



Duration: Contract



Work Location: Remote




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



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

Contact: hsharma04@judge.com


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