Regulatory Affairs Senior Associate
The Judge Group Inc.

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

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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