Head of Regulatory Affairs
2 months ago
Director of Regulatory Affairs
EPM Scientific is seeking a skilled Director of Regulatory Affairs to lead our initiatives in navigating the intricate regulatory environment associated with innovative therapies. This position is critical for ensuring that our pioneering projects in gene therapy are successfully advanced through the regulatory framework.
In this essential role, you will leverage your strategic insights and practical experience to manage regulatory obligations and spearhead vital submission processes. This is an exceptional opportunity for a proactive leader who excels in a collaborative and diverse setting. Your contributions will be vital in bringing our cutting-edge therapies to market, as you develop effective regulatory strategies and facilitate smooth communications with health authorities worldwide.
Key Responsibilities:
- Address complex scientific challenges and align them with regulatory strategies to create successful pathways.
- Lead the development and submission of comprehensive regulatory documents and clinical trial applications, working closely with cross-functional teams and showcasing superior writing skills.
- Act as the primary point of contact with global health authorities, ensuring clear and proactive communication to meet project objectives.
- Ensure adherence to international regulatory standards for gene therapy products, including the creation and review of essential documentation.
- Collaborate with Nonclinical, Technical Operations, Quality Assurance, and Clinical teams to meet timelines and secure prompt approvals.
Qualifications:
- A Bachelor’s degree in a relevant life sciences discipline with a minimum of 8 years of experience in the biopharmaceutical sector, particularly in biologics and regulatory affairs.
- Experience in gene or cell-based therapies, RNA therapeutics, or orphan drug development is highly desirable.
- Demonstrated success with BLA or MAA submissions and extensive familiarity with global regulatory agencies and submission types.
- Outstanding communication abilities, strategic leadership skills, and a dedication to high-quality, detail-oriented work.
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Head of Regulatory Affairs
2 months ago
Massachusetts, United States EPM Scientific Full timeDirector of Regulatory AffairsEPM Scientific is seeking an accomplished Director of Regulatory Affairs to lead our innovative initiatives in the field of gene therapy. This role is crucial in navigating the intricate regulatory environment to ensure our cutting-edge therapies reach the market efficiently and effectively.In this influential position, you will...
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