Pharma Regulatory Submissions Consultant

Job Title: Pharma Regulatory Submissions Consultant

Department: Regulatory Affairs

 

Position Summary:

The Regulatory Submissions Specialist is responsible for preparing, compiling, and managing regulatory submissions to global health authorities (e.g., FDA, EMA, MHRA, Health Canada) in compliance with applicable regulations, guidelines, and company standards. This role supports the planning, execution, and tracking of submission activities for investigational and marketed products across all phases of the product lifecycle.

The individual works closely with cross-functional teams — including Clinical, CMC, Quality, Medical Writing, and Regulatory Strategy — to ensure timely, accurate, and compliant submissions.

Key Responsibilities:

• Prepare, compile, review, and publish regulatory submissions (e.g., IND, CTA, NDA, MAA, Annual Reports, Amendments, and Responses to Health Authority Queries).
• Ensure all submissions comply with ICH, regional, and electronic submission standards (e.g., eCTD).
• Manage and track submission timelines, deliverables, and document readiness to meet project milestones.
• Collaborate with internal departments and external partners (e.g., CROs, vendors) to collect and verify submission content.
• Support regulatory operations workflows including document formatting, hyperlinking, bookmarking, and lifecycle management.
• Maintain submission records and archival in Regulatory Information Management (RIM) and Document Management Systems (DMS) (e.g., Veeva Vault RIM, Lorenz docuBridge, eCTDmanager).
• Coordinate submission publishing and transmission to health authorities, ensuring technical validation success.
• Support regulatory inspections and audits by providing accurate documentation and traceability.
• Participate in process improvements, system enhancements, and SOP updates related to submission management.
• Provide training and guidance to internal teams on submission standards and document requirements.

Qualifications:

Education:

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.

Experience:

• 2–6 years of experience in regulatory submissions or regulatory operations within a pharmaceutical, biotech, or CRO environment.
• Strong understanding of global submission formats (eCTD, NeeS, paper, etc.) and related regulatory guidelines (ICH, FDA, EMA).
• Hands-on experience with publishing tools and RIM/DMS systems (e.g., Veeva Vault RIM, Lorenz, Extedo, GlobalSubmit, or similar).
• Familiarity with clinical development processes, CMC, and regulatory lifecycle management.

Skills:

• Exceptional attention to detail and strong organizational skills.
• Ability to manage multiple projects and prioritize under tight timelines.
• Strong communication and cross-functional collaboration abilities.
• Proficiency in Microsoft Office and electronic submission tools.
• Working knowledge of Good Regulatory Practices (GRP) and data integrity principles.

Preferred Qualifications:

• Experience with global submissions (EU, APAC, LATAM regions).
• Understanding of xEVMPD/IDMP data standards.
• Experience supporting marketing authorization applications or variations/supplements.
• Involvement in system implementation or process optimization projects.