Director/Senior Director, Global Regulatory Affairs

🕒 May 21

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Secura Bio, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

💰 $90M Debt Financing - Secura Bio on 2019-03

Biotechnology • Pharmaceuticals

Secura Bio, Inc. is a commercial-stage biopharmaceutical company focused on developing, commercializing, and optimizing oncology therapies. The company emphasizes commercial strategy and market access for oncology medicines, supported by clinical development capabilities (clinical trials, expanded access, investigator-sponsored studies), medical education, and patient support programs. Headquartered in Berkeley Heights, New Jersey with an office in Dublin, Ireland, Secura Bio positions itself to maximize commercial outcomes for cancer treatments such as duvelisib.

📋 Description

• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions • Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries • Oversee preparation and submission of regulatory documents • Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals • Provide strategic input to leadership on regulatory risk and risk mitigations • Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders • Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness • Represent regulatory interests in product development governance committees and decision-making processes

🎯 Requirements

• Advanced degree in life sciences, pharmacy, or related field preferred • 10+ years of progressive experience in regulatory affairs within the biotechnology/pharmaceutical industry • Minimum of 5 years experience in the hematology/oncology field • Demonstrated track record of successful regulatory submissions and agency interactions • Comprehensive understanding of FDA, EMA, and other major health authority regulations • Experience with successful product approvals • Strong leadership abilities with 3+ years managing regulatory teams • Excellent communication and interpersonal skills for effective cross-functional collaboration • Strategic thinking with ability to translate complex regulatory frameworks into practical guidance • Demonstrated ability to work collaboratively with internal and external stakeholders to achieve consensus in complex and ambiguous situations • Deep knowledge of GxP requirements and their implementation • Ability to operate in a fast-paced environment.