Associate Director, Regulatory Operations

The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining the company's regulatory submission standards and current electronic submission guidelines/requirements.

This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and submission of Investigational New Drug applications (INDs), New Drug applications (NDAs), annual reports, Development Safety Update Reports (DSURs), and safety reports to regulatory authorities.

Responsibilities and Duties

Manage regulatory operations activities, ensuring timely and accurate regulatory submissions, and collaborating with cross-functional teams for our US, EU, UK and Health Canada regions

Identify/address opportunities to enhance operational effectiveness and drive process improvements within the department

Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes

Support development program projects by collaborating with multi-disciplinary project teams to ensure successful program deliverables

Assist in the development of Standard Operating Procedures (SOPs) quality assurance, and records management practices related to regulatory operations activities

Track regulatory department information such as commitments with health authorities and NDA/IND commitments

Act as an expert resource for eCTD submissions to FDA, ensuring compliance with internal and health authority standards

Support the development and maintenance of operations resources for submission documents

Identify new or revised regulatory policies and initiate activities to support compliance

Participate in special projects and process improvement initiatives

Qualifications and Skills

Bachelorâ s degree in life/physical sciences or related field

8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations

Knowledge and understanding of the drug development process

Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure

Experience with Veeva RIM EDMS

Highly proficient in Microsoft Office suite

Ability to balance both strategic and operational approaches, “think outside the box” and to manage multiple tasks in a fast-paced environment

Detail-oriented and highly organized

Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders