About the role
What you will do
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 execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
To assist the Global Regulatory Lead to manage GRT interactions
Key responsibilities include:
- Assist US Regulatory Lead to support local 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 US Regulatory Lead
- Create and maintain product regulatory information and history documents through Client systems
- Appropriately archive regulatory documents and agency communications
- Collaborate with CRO’s / partners to support site initiation
- Complete regulatory forms to support agency communications
- 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)
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Actively support regulatory compliance
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.
Preferred Qualifications:
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to collaborate with team members to tackle problems and develop a course of action
- Cultural awareness and sensitivity to achieve global results
- Planning and organizing abilities
- Able to prioritize and balance multiple activities
- Ability to deal with ambiguity
- Ability to influence others
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
- Planning and organizing abilities
- Prior regulatory knowledge experience as a clinical strategist (Preferred)
- FDA experience is a bonus
Day to Day Responsibilities:
- Assist US Regulatory Lead to support local 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 US Regulatory Lead
- Create and maintain product regulatory information and history documents through Client systems
- Appropriately archive regulatory documents and agency communications
- Complete regulatory forms to support agency communications
- 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)
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Actively support regulatory compliance
Note: Overqualified candidates with more than 3 years' experience
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