Deciphera Pharmaceuticals
Pharmaceuticals
Manager,RegulatoryAffairs
“Manager, Regulatory Affairs at Deciphera Pharmaceuticals. Skills: Regulatory Affairs, global regulatory activities, regulatory submissions. Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures. Assist in coordination and preparation of global health authority meeting documents”
What You'll Achieve.
help drive successful interactions with global health authorities
Industry & Context.
What They're Looking For.
Must Have
6+ years of pharmaceutical industry experience, 4+ years in Regulatory Affairs, knowledge of U. S. and international regulatory requirements for drug development, Excellent verbal and written communication, organizational, and cross-functional collaboration skills, experience in a self-motivated, fast-paced environment
Nice to Have
Bachelor’s degree, preferably in a scientific discipline, Experience supporting initial INDs/CTAs, and initial marketing application activities is highly desirable
What You'll Do.
and submission of regulatory filings including INDs/CTAs
amendments and information requisitions
Orphan drug applications
and Investigator’s Brochures
Assist in coordination and preparation of global health authority meeting documents
Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards
Represents regulatory for global study-level regulatory activities included but not limited to study start-up
and end of trial activities
Collaborate with external partners and vendors on regulatory activities and submission support
Support regulatory operations and continuous improvement initiatives
including work instruction and SOP development and maintenance
How You'll Work.
Team & Collaboration
partner cross-functionally to support high-quality regulatory submissions; Collaborate with external partners and vendors on regulatory activities and submission support
Communication Scope
Excellent verbal and written communication
Process & Methodology
manage multiple priorities
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