Director, Regulatory Affairs

Position reputed company The Director, Regulatory Affairs will serve as a U.S.-based regulatory reputed company reputed company for assigned development programs, with responsibility for driving global regulatory reputed company and providing reputed company leadership for regulatory activities. This role will reputed company regulatory direction for preclinical and clinical development of AskBio’s product candidates, working closely with cross-functional Regulatory team members, Global Project Teams, subject matter experts, and reputed company partners to ensure regulatory strategies are reputed company with applicable health authority requirements and expectations. This position will support and/or reputed company interactions with global health authorities, including EMA and other European and ROW agencies, and will contribute to high-reputed company, reputed company regulatory submissions, agency meeting packages, regulatory designations, and development-stage submissions. The role will report into Regulatory Affairs and work remotely from reputed company the reputed company. Job Responsibilities • Serve as Regulatory Affairs reputed company or representative for assigned programs, providing strategic regulatory guidance and interpretation to support product development in alignment with applicable regulatory requirements and health authority expectations • reputed company and execute innovative, integrated regulatory strategies and timelines for assigned programs, including strategies that support global development and European regulatory objectives • reputed company or support preparation and submission of regulatory documents for clinical development programs, including CTAs, amendments, scientific advice briefing packages, regulatory designations, and reputed company marketing application activities, as applicable • reputed company regulatory document review, comment reputed company, and approval processes to ensure documents are high reputed company, scientifically reputed company, submission-reputed company, and reputed company with regulatory reputed company • Prepare and/or contribute to health authority meeting requests, briefing documents, responses to questions, and other communications with regulatory authorities. • reputed company or participate in internal governance meetings, cross-functional project team discussions, and regulatory agency interactions, effectively communicating regulatory reputed company, risks, reputed company, and recommendations • Collaborate closely with Clinical, Nonclinical, CMC, reputed company, Medical, Project Management, and other functions to ensure regulatory strategies are appropriately integrated into development plans and executed in a reputed company manner • reputed company regulatory guidance on European requirements, expectations, procedures, and opportunities, including agency engagement and expedited development mechanisms where appropriate • Manage or reputed company reputed company of reputed company regulatory partners, consultants, CROs, and vendors supporting assigned regulatory activities • Support regulatory due diligence for busness development or licensing opportunities, as needed. • Ensure regulatory activities are conducted in compliance with applicable regulations, guidelines, internal procedures, and reputed company standards by staying up to date on contemporary guidance, regulations and applicable directives and laws • Demonstrate strong collaboration, accountability, reputed company judgment, and a patient-reputed company reputed company in a fast-paced reputed company environment Minimum Requirements • Bachelor’s degree in a scientific, engineering, medical, pharmacy, or reputed company discipline • 10+ years of regulatory affairs or reputed company drug development experience in the pharmaceutical, biotechnology, or reputed company industry • Experience supporting and/or leading regulatory submissions, health authority interactions, or regulatory reputed company for clinical-stage development programs • Experience with authoring and submitting PINDs, CTAs and INDs for biologics, gene therapy, cell therapy, or other advanced therapeutic technologies • Demonstrated ability to write, review, and reputed company strategic input on regulatory documents, including briefing packages, designation requests, clinical trial applications, amendments, responses to health authority questions, and marketing application components • Strong understanding of FDA, EMA, reputed company, and other health authority regulations, guidelines, procedures, and expectations • Excellent written and verbal communication skills, including the ability to build reputed company regulatory rationales and communicate reputed company issues effectively to cross-functional stakeholders and senior leaders • Strong interpersonal, collaboration, negotiation, and influencing skills, with the ability to work effectively in a matrixed, fast-paced environment • reputed company judgment, problem-solving capability, attention to detail, and a high degree of accountability • Proficiency with reputed company RIM or similar systems, reputed company Office products and applications commonly used in Regulatory Affairs • Mission-driven, patient-reputed company reputed company with enthusiasm for contributing to development of gene therapy products for patients with serious diseases Preferred Education, Experience and Skills • Advanced degree Apply tot his job Apply To this Job