Senior Associate - Regulatory Affairs (US-Remote)
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Senior Associate - Regulatory Affairs. In this role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. Responsibilities
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 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 Amgen 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 Qualifications
Required: Master’s degree Required: Bachelor’s degree and 2 years of Regulatory Affairs experience Required: Associate’s degree and 6 years of Regulatory Affairs experience Required: High school diploma / GED and 8 years of Regulatory Affairs experience Preferred: Strong communication skills - both oral and written Preferred: Ability to understand and communicate scientific/clinical information Preferred: Ability to collaborate with team members to tackle problems and develop a course of action Preferred: Cultural awareness and sensitivity to achieve global results Preferred: Planning and organizing abilities Preferred: Able to prioritize and balance multiple activities Preferred: Ability to deal with ambiguity Preferred: Ability to influence others Skills
Strong communication (oral and written) Ability to understand and communicate scientific/clinical information Collaboration and problem-solving Cultural awareness for global results Planning, organizing, prioritization Ability to work with ambiguity and influence others Education
Details aligned with Basic Qualifications above
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Senior Associate - Regulatory Affairs. In this role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. Responsibilities
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 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 Amgen 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 Qualifications
Required: Master’s degree Required: Bachelor’s degree and 2 years of Regulatory Affairs experience Required: Associate’s degree and 6 years of Regulatory Affairs experience Required: High school diploma / GED and 8 years of Regulatory Affairs experience Preferred: Strong communication skills - both oral and written Preferred: Ability to understand and communicate scientific/clinical information Preferred: Ability to collaborate with team members to tackle problems and develop a course of action Preferred: Cultural awareness and sensitivity to achieve global results Preferred: Planning and organizing abilities Preferred: Able to prioritize and balance multiple activities Preferred: Ability to deal with ambiguity Preferred: Ability to influence others Skills
Strong communication (oral and written) Ability to understand and communicate scientific/clinical information Collaboration and problem-solving Cultural awareness for global results Planning, organizing, prioritization Ability to work with ambiguity and influence others Education
Details aligned with Basic Qualifications above
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