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Key Responsibilities and Required Skills for Regulatory Operations Specialist

💰 $65,000 - $110,000

Regulatory AffairsOperationsLife Sciences

🎯 Role Definition

The Regulatory Operations Specialist owns executional excellence for regulatory submission lifecycle and regulatory intelligence operations across global markets. This role coordinates dossier assembly, eCTD publishing, submission tracking, agency correspondence support, and process improvement in a GxP-compliant environment. The ideal candidate is experienced with eCTD/CTD/Module formats, regulatory document management systems (e.g., Veeva Vault, eCTD Gateway), and cross-functional stakeholder engagement to enable timely approvals and product lifecycle management.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Regulatory Coordinator / Regulatory Assistant
  • Clinical Trials Assistant / Clinical Research Coordinator
  • Quality Assurance Associate or Document Control Specialist

Advancement To:

  • Senior Regulatory Operations Specialist
  • Regulatory Operations Manager / Regulatory Affairs Manager
  • Global Regulatory Affairs Lead or Head of Regulatory Operations

Lateral Moves:

  • Quality Assurance Specialist / Regulatory Compliance Specialist
  • Clinical Project Manager / Program Manager (Clinical Development)

Core Responsibilities

Primary Functions

  • Lead end-to-end preparation, compilation and quality review of regulatory submission dossiers (CTD/eCTD and non-CTD formats) for global authorities including FDA, EMA, Health Canada and other regional agencies, ensuring content accuracy, format compliance and timely submission.
  • Coordinate eCTD publishing operations with internal publishing teams and external vendors, including validation of publish outputs, resolving publishing errors and ensuring successful electronic gateway transmissions.
  • Manage submission timelines and trackers for regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, supplements), proactively identifying critical path risks and implementing mitigation plans to meet regulatory timelines.
  • Prepare and maintain submission-ready administrative documentation including transmittal letters, cover pages, regional checklists, validation reports, and submission confirmation records.
  • Facilitate global submission planning calls and cross-functional meetings (Regulatory Affairs, CMC, Clinical, Quality, Legal, Medical Affairs) to align on dossier content, regulatory strategy and filing timelines.
  • Maintain and administrate regulatory document management systems (e.g., Veeva Vault, MasterControl, Documentum), ensuring metadata integrity, version control and secure access for regulated documents.
  • Perform detailed regulatory quality control (QC) and quality assurance (QA) checks on documents and dossiers to ensure adherence to SOPs, regulatory guidelines and company quality standards.
  • Support labeling and artwork change management processes by coordinating regulatory reviews, compiling history files and submitting labeling changes or variations to appropriate health authorities.
  • Track and respond to regulatory authority requests for information (RFIs), deficiency letters, or queries in collaboration with subject matter experts, preparing timely and compliant responses.
  • Manage publishing budgets, vendor contracts and service level agreements (SLAs) for external vendors supporting submission publishing, archiving and regulatory intelligence.
  • Maintain submission archives and regulatory history databases for product lifecycles, ensuring searchable records for audits, inspections and product stewardship.
  • Implement process improvements and standard operating procedures to streamline submission workflows, reduce rework and accelerate regulatory approvals.
  • Support regulatory inspections and audits by preparing evidence packages, facilitating document retrievals and coordinating responses to audit findings.
  • Coordinate global dossier translations and region-specific content insertion, ensuring correct regional annexes and country-specific modules are included before submission.
  • Monitor global regulatory requirements and guidance updates, performing regulatory intelligence analysis and advising the regulatory team on impacts to ongoing and planned submissions.
  • Oversee electronic submission gateways and troubleshoot submission rejections or transfer failures with IT, vendors and regulatory agencies to obtain successful receipt confirmations.
  • Support regulatory project management activities including creating submission timelines, maintaining Gantt charts, escalating delays and providing regular status reports to senior management.
  • Assist with product lifecycle regulatory activities such as renewals, variations/changes, post-approval commitments, line extensions and labeling maintenance across global portfolios.
  • Ensure compliance with GxP, company SOPs, and industry standards (ICH, CTD format, eCTD specifications) through documentation, training and continuous improvement initiatives.
  • Train and mentor junior regulatory operations staff and cross-functional partners on submission processes, eCTD standards, document management practices and regulatory timelines.
  • Prepare management and KPI reports related to submission velocity, cycle times, publishing error rates and regulatory workload to inform leadership decision-making.
  • Support cross-functional due diligence activities for licensing, mergers & acquisitions or product transfers by compiling regulatory dossiers, submission histories and regulatory compliance evidence.

Secondary Functions

  • Provide ad-hoc data analysis and reporting to support regulatory strategy and operations decision-making, including extraction of metrics from document management systems.
  • Participate in validation activities for electronic systems (e.g., eCTD validators, DMS) and support change control documentation related to regulatory tooling.
  • Contribute to the design and maintenance of submission templates, cover letter libraries and regulatory checklists to improve consistency and speed of filings.
  • Manage archival and retention schedules for electronic submission packages and regulatory correspondence in accordance with regional requirements.
  • Act as regulatory liaison for external vendors (publishers, translation vendors, archiving services) to ensure quality and compliance with service level agreements.
  • Assist in budget planning for regulatory operational activities and vendor services, tracking spend and advising on cost efficiencies.
  • Support regulatory risk assessments for submission approaches, identifying dependencies and advising project teams on mitigation pathways.
  • Coordinate training programs and onboarding for new regulatory operations hires and cross-functional stakeholders on publishing workflows and dossier standards.
  • Collaborate with IT and cybersecurity teams to ensure secure transmission of regulatory information and integrity of submission packages.
  • Participate in pilot programs to adopt new regulatory technologies (eCTD automation, AI-assisted QC tools) and provide operational feedback for implementation.

Required Skills & Competencies

Hard Skills (Technical)

  • Proven experience with eCTD publishing workflows, eCTD validators and electronic gateway submissions (FDA ESG, EMA, regional gateways).
  • Deep familiarity with CTD structure (Modules 1–5), dossier compilation, regional dossier requirements and lifecycle submissions (NDAs, MAAs, INDs).
  • Hands-on experience with regulatory document management systems such as Veeva Vault, MasterControl, Documentum or similar EDMS.
  • Strong knowledge of regulatory guidelines and standards (ICH, GxP, eCTD specifications, regional submission guidances).
  • Proficiency with submission tracking tools, project management software (e.g., MS Project, Jira, Smartsheet) and advanced Excel for tracking and reporting.
  • Experience with labeling change processes, artwork coordination and regulatory content insertion for regional submissions.
  • Experience managing external publishing vendors and familiarity with publisher deliverables, validation reports and SLAs.
  • Competence in preparing regulatory correspondence, transmittal documentation, submission validation reports and regulatory archives.
  • Familiarity with quality systems and document control, including SOP drafting, change control and audit readiness.
  • Understanding of clinical and CMC dossier components to coordinate and integrate cross-functional inputs into submissions.
  • Experience with electronic archiving, metadata standards and records retention policies for regulatory submissions.
  • Knowledge of submission risk assessment and mitigation planning, including handling deficiency responses and post-approval commitments.

Soft Skills

  • Exceptional attention to detail with strong editorial and document QC skills to detect formatting and content inconsistencies.
  • Strong project management and organizational skills with the ability to prioritize competing deadlines in fast-paced environments.
  • Clear oral and written communication skills for liaising with regulatory agencies, internal stakeholders and external vendors.
  • Collaborative team player able to influence and coordinate across functional groups (CMC, Clinical, Quality, Legal).
  • Problem-solving mindset with the ability to troubleshoot publishing issues and escalate appropriately.
  • Adaptability and continuous learning orientation to stay current with evolving regulatory standards and submission technologies.
  • Strong stakeholder management and negotiation skills for vendor management and cross-functional alignment.
  • Time management and multitasking ability to handle multiple concurrent submissions and lifecycle activities.
  • Integrity and professionalism when handling confidential regulatory information.
  • Leadership potential to mentor junior staff and drive operational improvements.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in life sciences, pharmacy, chemistry, biomedical engineering, or a related field.

Preferred Education:

  • Master's degree in Regulatory Affairs, Regulatory Science, Pharmacy, Life Sciences, or MBA.
  • Professional certification such as RAC (Regulatory Affairs Certification) or equivalent regulatory training.

Relevant Fields of Study:

  • Regulatory Affairs / Regulatory Science
  • Pharmacy, Pharmaceutical Sciences
  • Biology, Biotechnology, Biochemistry
  • Chemistry, Chemical Engineering
  • Biomedical Engineering

Experience Requirements

Typical Experience Range:

  • 2–6 years of progressive experience in regulatory affairs, regulatory operations, publishing or document management in pharmaceutical, biotech or medical device industries.

Preferred:

  • 3–7 years of hands-on experience with eCTD publishing, global submissions (FDA/EMA/row), and regulatory document management systems.
  • Demonstrated experience coordinating cross-functional dossier assembly for commercial and lifecycle filings.
  • Prior exposure to regulatory inspections, audits or submission deficiency responses preferred.
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