The Head of Regulatory Affairs will be responsible for overseeing industry-specific practices and ensures all government and company regulations are being met. The ideal candidate will have 5+ years of experience in managing regulatory affairs in the biotech industry. The Head of Regulatory Affairs will also have excellent written and oral communications skills. The position will report directly to the Executive Vice President of Operations and Regulatory Affairs and other top level management with a focus on meeting company established goals and timelines.
The candidate will be completely aligned with four fundamental pillars of Landos’ entrepreneurial corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- Assessing the company’s compliance with industry regulations, both external and internal.
- Developing and advising on new policies for the company.
- Mentoring new hires under the regulatory affairs division of the company.
- Identify, assess and communicate potential project challenges and conduct risk mitigation strategies pertaining to regulatory affairs.
- Maintain a current knowledge of industry-specific regulations and guidance.
- Independently plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure compliance within the organization.
- Recommends direction for key operations and new initiatives in collaboration with local and global stakeholders.
- Lead team members that provide regulatory affairs content and requirements for regulatory submissions and reviews this content for conformance with established requirement.
- Manages and develops staff, if required, including staff professional development and project oversight accountability.
- Represents Landos Regulatory Affairs in meetings and leads preparation activities for meetings with Health Authorities on regulatory affairs related matters
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provides solutions to prevent recurrence of issues.
- Stays abreast of current and evolving regulatory requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
- Ensuring all necessary regulatory applications are filed timely.
- Creating functional strategies and specific objectives for the regulatory affairs department and developing budgets/policies/procedures to support the regulatory affairs infrastructure.
- Proven ability to liaise with Regulatory Agencies; international experience preferred.
- Maintain the confidentiality of all the company deliberations and plans.
- Faithfully performs any other tasks requested by the Chairman, President and CEO.
- Team-science oriented, data-driven, and patient-centric engendering credibility and confidence within and outside the company.
- Act in accordance with Landos’ policies and in alignment with Landos’ corporate culture.