Regulatory Operations Consultant - Pharma

The Regulatory Operations Consultant will be responsible for end-to-end document and submission publishing, including planning, compiling, publishing, delivering, and archiving of regulatory submissions.

EXPERIENCE IN THE PHARMACEUTICAL INDUSTRY AND REGULATORY OPERATIONS IS REQUIRED.

The Regulatory Operations Consultant is responsible for managing the preparation and submission of high-quality regulatory dossiers in the US and the EU according to set timelines.

• Prepare and review sections of regulatory submissions; from INDs/CTAs and BLAs/MAAs, including original submission and amendments/supplements
• Track and report on deliverables for major milestone submissions including original submission and amendments/supplements
• Ensure planning and proper organization of submission activities in line with the overall project plan and milestones, raising risks for resolution
• Support report publishing and signoff utilizing templates, RIMs, and eSignature technology in accordance with Quality standards.
• Lead preparation of meetings with regulatory agencies and actively participate in regulatory meetings.
• Drive adherence to regulatory guidelines for the development of cell and gene therapy products
• Assist team during regulatory agencies' inspections.
• Participate in regulatory intelligence activities; monitor regulatory guidelines and trends.

Minimal Qualifications:

• Bachelor’s degree (or equivalent) in relevant scientific or life sciences discipline
• Experience in the pharmaceutical industry, with at least 6 years of direct experience in regulatory operations/submission publishing
• Knowledge of eCTD publishing systems and relevant publishing tools
• Demonstrated success managing the preparation, publication, and transmission of regulatory submissions including original INDs and amendments, and NDAs/BLAs; experience with EU CTAs and MAAs is a plus.
• Detail-oriented with excellent oral and effective writing and editing skills, including proficiency in technical writing.
• Understanding of the drug development process from pre-IND through registration and post-registration required
• Understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).

Job Types: Part-time, Contract

Pay: $45.00 - $60.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 4 hour shift

Application Question(s):

• Do you have experience formatting IND's specifically?

Experience:

• regulatory Operations: 4 years (Preferred)
• regulatory submissions: 4 years (Preferred)

Work Location: Remote