Head of Regulatory Compliance
1 week ago
The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader for various regulatory projects at different stages of development. This position requires a strategic mindset to guide drug development initiatives and ensure adherence to regulatory standards.
Key Responsibilities:
- Oversees the strategic planning, preparation, and submission of intricate regulatory documents to meet project objectives.
- Directs the creation of comprehensive meeting packages and orchestrates meeting strategies to ensure effective team readiness.
- Contributes to policy formulation and the enhancement of global operational processes.
- Maintains up-to-date knowledge of regulatory requirements in the US, EU, and ICH, and proactively communicates any changes within the organization.
- Stays informed about evolving regulations and health authority actions, utilizing this knowledge to shape regulatory strategies.
- Acts as a strategic regulatory authority for assigned drug development initiatives, advising project teams on compliance to facilitate successful global strategies.
- Leads cross-functional teams to ensure the delivery of high-quality submissions, including INDs, NDAs/BLAs, and other regulatory documents, while providing mentorship and guidance to team members.
- Serves as the primary contact for Health Authorities regarding assigned products.
- Engages in negotiations with Health Authorities and aids in interpreting their feedback.
- Builds and nurtures relationships with both internal and external stakeholders, integrating regulatory and drug development insights to promote collaboration and achieve organizational goals.
Qualifications:
- A Bachelor's degree in life sciences is required; an advanced degree is preferred.
- A minimum of 8 years of relevant experience in regulatory affairs is essential.
- Experience with NDA/BLA submissions is required.
- Proven experience in developing regulatory strategies for products aimed at treating chronic and severe life-threatening diseases.
- Familiarity with document management systems and RIMS is necessary.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is expected.
- A strategic thinker with the ability to interpret complex regulations and apply them effectively throughout the product development lifecycle.
- Strong analytical and problem-solving skills are essential.
- Excellent verbal and written communication skills are required, with the ability to effectively engage with Health Authorities and diverse peer groups.
- Capability to negotiate innovative development and registration pathways for rare diseases.
- Demonstrated success in a dynamic and culturally diverse work environment, both remotely and in person.
- Ability to formulate global regulatory strategies for products targeting chronic and severe life-threatening conditions.
- Occasional travel may be required for meetings and conferences, not exceeding 15% of the time, subject to business needs.
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