Regulatory Affairs Specialist

This is a six month contract with a likelihood of extension or conversion.

The Client is seeking an experienced and highly motivated Regulatory Affairs professional to support global regulatory submissions and interactions with health authorities. This role will be responsible for maintaining regulatory archives and trackers, coordinating with external publishing partners, and managing day-to-day regulatory operations. The ideal candidate is a hands-on, self-starter who thrives in collaborative environments and brings proven experience supporting global clinical development programs.

Key Responsibilities

• Lead or support the preparation, review, and finalization of high-quality regulatory submissions in compliance with global health authority requirements.
• Serve as the primary point of contact for assigned projects, providing regulatory document and submission management under limited supervision.
• Partner with external eCTD publishing vendors to ensure timely and accurate submissions.
• Manage and maintain regulatory submission trackers, archives, and health authority commitment trackers.
• Collaborate cross-functionally with Quality and other departments to ensure data integrity and consistency across submissions.
• Support global clinical development programs, including INDs, CTAs, and associated regulatory documentation.

Education, Experience, and Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Clinical, Biological, or related field); an advanced degree is preferred.
• 4–5 years of Regulatory Affairs experience in Biotechnology, Biopharmaceutical, or Pharmaceutical industries; experience with monoclonal antibodies or biologics is a plus.
• Demonstrated experience supporting regulatory submissions in product development, including INDs (US) and CTAs (EU, Australia, Asia).

Required Skills and Experience

• Strong scientific background with the ability to apply knowledge to regulatory strategy and requirements.
• Solid understanding of global health authority guidelines and processes (ICH, CFR, EMA, FDA).
• Proven submission management skills, with the ability to coordinate teams and drive timelines for timely submissions.
• Technical proficiency with Windows, Adobe, and eCTD software.
• Highly organized, detail-oriented, and able to manage multiple priorities simultaneously.
• Strong problem-solving skills with the ability to anticipate and resolve roadblocks.
• Excellent interpersonal skills, fostering effective cross-functional collaboration.

Preferred Skills and Experience

• Background in oncology and late-stage (Phase II/III) clinical development programs.
• Experience with antibody-based therapeutics and biologics.
• Prior involvement in rare disease or autoimmune drug development.
• Experience supporting a broad range of regulatory submissions throughout clinical development.
• Familiarity with finalizing Nonclinical Reports and Investigator’s Brochures.
• Advanced expertise in regulatory document formatting (MS Word).
• Experience reviewing complex eCTD publishing outputs.