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Associate Director, Regulatory Operations

The Steely Group

Hybrid, Boston, MA

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Cross-Functional, Detail Oriented, Drug Development, FDA (Food and Drug Administration), Health Canada, Interpersonal Skills, Investigational New Drug (IND), Maintain Compliance, Microsoft Office, Multitasking, New Drug Application, Operational Strategy, Operations Management, Organizational Skills, Pharmacovigilance, Physical Science, Process Improvement, Quality Assurance, Records Management, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Submissions, Standard Operating Procedures (SOP), Standards Development, Team Player, Time Management
LOCATION
Hybrid, Boston, MA
POSTED
27 days ago
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
  • Bachelor’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
     

About the Company

T

The Steely Group

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