Manager/Senior Manager Regulatory Affairs

Job Title: Manager/Senior Manager, Regulatory Affairs

Location: Fully Remote

Therapeutic Area: Oncology/Solid Tumors

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We are seeking an experienced and motivated Manager/Senior Manager Regulatory Affairs to join our team. In this role, you will be responsible for managing, evaluating, and completing regulatory projects consistent with company goals. As the Manager/Senior Manager Regulatory Affairs, you will play a crucial role in ensuring timely planning and coordination of regulatory submissions, while providing guidance to cross-functional teams on regulatory strategy and tactics.

Responsibilities:

• Assist in the development and implementation of strategies to achieve the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
• Maintain compliance with regulatory requirements, ensuring that regulatory submissions are up-to-date and accurate. Support and manage the preparation of meeting requests and briefing documents.
• Collaborate with external regulatory consultants/CROs as necessary.
• Independently plan and manage regulatory activities related to assigned projects, covering areas such as clinical, non-clinical, and CMC, with minimal supervision.
• Manage the preparation, review, and timely submission of regulatory dossiers required for investigation and registration of products in relevant markets.
• Participate in cross-functional project teams, providing regulatory expertise and guidance.
• Stay current with regulatory knowledge and inform management of significant developments. Ensure compliance with departmental requirements, including the maintenance of regulatory archives.
• Lead the preparation, review, and submission of all components of regulatory submissions, including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.

Education Required:

• BA/BS degree or equivalent experience in a pharmaceutical or health science field is required.

Qualifications:

• Superior planning skills, with strong attention to detail.
• Knowledge/experience with regulatory requirements for other regions is desirable.
• Understanding of FDA structure and function.
• Familiarity with CTD/eCTD and experience in publishing documents using Adobe Acrobat Professional.
• Minimum of 7 years of related experience in regulatory affairs is required.
• Self-starter with the ability to work effectively in an entrepreneurial, fast-paced environment.
• Working knowledge of FDA and ICH regulatory guidance and regulations.
• Excellent oral and written communication skills.
• Strong understanding of GMP, GLP, and GCP regulations, as well as the pharmaceutical product life cycle.
• Experience and knowledge in the preparation of INDs (required) and NDAs (desirable), along with supportive amendments and supplements in manufacturing, nonclinical, and clinical areas.

Note: This job description is intended to provide a general overview of the position and may not include all the responsibilities and qualifications required for the role.