Assoc. Director, Regulatory Operations- Hybrid (Pennsylvania)

A Biotechnology Research company is currently looking to bring on an Associate Director, Regulatory Operations to the team. This role is responsible with preparing submissions, planning & tracking submission timelines, creating and maintaining SOPs to ensure activities are process driven with clear definitions for roles/responsibilities. In addition, this role will work with the Regulatory affairs team and other key stake holders serving as a regulatory knowledge source to ensure all aspects of regulatory submissions are planned and executed according to FDA and other global agency requirements.

• Position: Associate Director, Regulatory Operations
• Contract length: 12+ months W2
• Location: HYBRID- 1 x a week- King of Prussia, PA area
• Start Date: ASAP

Qualifications

• Bachelor's degree in pharmaceutical, science or related field; MS or other advanced degree preferred. RAC certification is a plus
• At least 10 years' experience in Biopharmaceutical or related scientific disciplines, with subject matter expertise in biologics or vaccine or cell & gene therapy product development or manufacturing
• At least 4 years of experience in regulatory affairs with a focus on preparation and submission of Regulatory submission in eCTD format, including response to agency questions, and briefing books Orphan Drug Designation submissions to FDA, EMA, MHRA, PMDA and Health Canada
• Proficient in strategic thinking, planning and implementing regulatory submission packages based on market specific requirements
• Veeva vault and Lorenz

Responsibilities:

• Point of Contact for Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical Development, Quality and Operations teams as appropriate
• Provides guidance and clear communications of regulatory risk(s) associated with development activities
• Serves as primary point of contact with FDA project manager for assigned projects
• With some supervision, leads the preparation of responses to Health authorities (US & Global)
• Interface with cross functional departments within client's and outside consultants to establish submission timelines, obtain on-time deliverables and ensure regulatory compliance for planned submissions in a Regulatory Operations project management role
• Responsible to perform final document review prior to finalization and conversion to a submission ready format
• Until submission capabilities are brought in-house, serve as a primary point of contact with external vendor for planned regulatory submissions to communicate submission content and timelines
• Maintain regulatory submission filing and Health Authority correspondence logs within a tracking system
• Responsible for initial entries of clinicaltrials.gov listings and bi-annual updated of client's sponsored clinical trials
• Monitors global health authority relations, guidelines and specifications including FDA, EMA, MHRA, Health Canada and ICH for regulatory submissions to ensure compliance
• Coordinate all aspects regulatory submissions relevant to assigned programs, including coordinating regulator workflow, reviewing technical documents (clinical and nonclinical), developing and tracking submission timelines and supervising preparation of regulatory submission to ensure compliance with FDA and global health authority regulations and guidelines

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real please visit www.realstaffing.com