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Key Responsibilities and Required Skills for Regulatory Affairs Specialist

💰 $70,000 - $110,000

Regulatory AffairsComplianceLife Sciences

🎯 Role Definition

The Regulatory Affairs Specialist develops and implements regulatory strategies to obtain and maintain market authorization for medicinal products and medical devices. This professional prepares regulatory submissions (e.g., IND, CTA, NDA/BLA, MAA, 510(k)), compiles and submits eCTD and paper dossiers, coordinates communications with global health authorities, ensures labeling and promotional compliance, supports post-market obligations (vigilance, device surveillance), and provides regulatory intelligence and risk-based guidance to cross-functional teams. The role requires deep knowledge of regulations, strong technical writing skills, and the ability to manage complex submission timelines.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Regulatory Affairs Coordinator or Regulatory Assistant
  • Quality Assurance Specialist or Quality Control Analyst
  • Clinical Research Associate (CRA) or Clinical Trial Coordinator

Advancement To:

  • Senior Regulatory Affairs Specialist
  • Regulatory Affairs Manager or Team Lead
  • Director of Regulatory Affairs or Head of Regulatory Affairs

Lateral Moves:

  • Quality Assurance / Compliance Management
  • Clinical Operations or Clinical Project Management
  • Medical Affairs or Product Lifecycle Management

Core Responsibilities

Primary Functions

  • Lead the development and execution of regulatory strategy for new product development and lifecycle management, aligning regulatory pathways (e.g., IND, CTA, NDA/BLA, MAA, 510(k), PMA) with business objectives and clinical development timelines.
  • Prepare, assemble and submit high-quality regulatory dossiers in CTD/eCTD format for global regulatory agencies (FDA, EMA, Health Canada, TGA, PMDA), ensuring completeness, accuracy and compliance with current guidance and format requirements.
  • Draft, review and finalize regulatory documents including cover letters, validation reports, regulatory briefs, responses to authority questions, and briefing packages for pre-submission meetings and agency interactions.
  • Manage agency interactions and meeting preparations (pre-IND, pre-NDA, scientific advice, pre-submission meetings), including creating meeting briefing documents, compiling supporting data, and coordinating cross-functional participation.
  • Coordinate and prepare submissions for clinical trial approvals and amendments (INDs, CTAs), ensuring alignment with clinical protocols, safety reporting obligations and CMC documentation.
  • Maintain regulatory submission trackers, timelines and project plans; proactively identify risks to milestones and implement mitigation plans to keep submissions on schedule.
  • Interpret evolving regulatory guidance, standards and legislation (e.g., FDA guidances, EMA guidelines, EU MDR/IVDR) and translate implications into actionable regulatory requirements for product teams.
  • Serve as primary point of contact for regulatory agency queries, drafting well-reasoned, evidence-based responses within agency timelines and ensuring rapid resolution of issues.
  • Collaborate closely with CMC, manufacturing and quality teams to compile CMC/CMC regulatory sections, batch records, stability data, and ensure compliance with GMP, labeling and release requirements.
  • Develop and maintain product labeling, instructions for use, packaging and promotional material to ensure regulatory compliance and consistency across markets; lead label change submissions and health-authority updates.
  • Support pharmacovigilance and post-market surveillance activities by coordinating adverse event reporting, periodic safety update reports (PSURs)/PBRER, and medical device vigilance reports, ensuring timely submission and regulatory compliance.
  • Prepare and submit variations, supplements and amendments (e.g., NDA supplements, MAA variations, device modifications), including justifications, risk assessments and supporting documentation.
  • Provide regulatory input into product development decisions, clinical study design, endpoint selection and comparator selection to optimize approval likelihood and regulatory acceptance.
  • Manage interactions with external vendors, regulatory consultants and CROs for dossier compilation, eCTD publishing, translations and submission logistics, ensuring quality and on-time deliverables.
  • Drive regulatory intelligence and competitive landscape analyses to inform lifecycle strategy, identify regulatory precedents and anticipate agency expectations or policy changes.
  • Ensure internal SOPs, work instructions and quality systems related to regulatory activities are current, and participate in audits and regulatory inspections, preparing responses and remediation plans as needed.
  • Prepare regulatory training materials and deliver cross-functional training on regulatory requirements, submission processes and compliance expectations to R&D, manufacturing and commercial teams.
  • Lead global submission harmonization efforts, assessing regional differences and creating region-specific modules, bridging global and local regulatory requirements for product registrations.
  • Oversee electronic document management and submission publishing processes (EDMS, eCTD publishers, publishing QC) to guarantee submission integrity and audit readiness.
  • Perform regulatory risk assessments and scenario planning for product changes, safety signals, manufacturing disruptions or regulatory policy shifts, guiding leadership on mitigation strategies and regulatory pathways.
  • Support pricing & reimbursement and market access teams by supplying regulatory documentation needed for health technology assessments, facilitating reimbursement submissions and post-market evidence generation.
  • Maintain and update regulatory filing dossiers and archiving systems to ensure retrieval of historical submission data, correspondence and authority decisions for lifecycle management.

Secondary Functions

  • Conduct regulatory gap analyses for new product concepts and support feasibility assessments and go/no-go decisions during development gates.
  • Support product launch activities by validating regulatory deliverables, confirming market authorizations and coordinating release timelines with supply chain and commercial teams.
  • Assist in responding to external audits and inspections, compiling evidence packages and leading corrective/preventive action implementation where regulatory non-conformances are identified.
  • Contribute to the creation of regulatory templates, checklists and standardized submission components to accelerate dossier preparation and ensure consistency.
  • Monitor global regulatory news, guidance updates and agency communications, disseminating relevant intelligence to product teams and updating project plans accordingly.
  • Support clinical trial regulatory maintenance by submitting safety updates, protocol amendments, investigator brochure updates and annual reports to authorities and ethics committees.
  • Participate in cross-functional risk reviews (e.g., Change Control Boards) to assess regulatory impact of manufacturing or formulation changes and advise on regulatory submission needs.
  • Assist with labeling and promotional compliance reviews to ensure all materials follow local regulatory and legal requirements prior to marketing.
  • Provide input to CAPA investigations when compliance gaps touch regulatory obligations and support root-cause analysis from a regulatory perspective.
  • Help maintain relationships with regulatory consultants and local registration agents to ensure smooth local submissions and country-specific compliance.

Required Skills & Competencies

Hard Skills (Technical)

  • Regulatory strategy development for pharmaceuticals, biologics, medical devices or combination products (IND/CTA, NDA/BLA, MAA, 510(k), PMA).
  • eCTD and CTD dossier preparation and publishing (hands-on experience with eCTD submissions and publishing tools).
  • In-depth knowledge of global regulatory frameworks: FDA, EMA, Health Canada, TGA, PMDA, and EU MDR/IVDR.
  • Strong technical writing and scientific communication skills for drafting regulatory submissions, responses and briefing documents.
  • Experience with CMC documentation, stability data interpretation, and submission of manufacturing-related modules.
  • Pharmacovigilance and post-market reporting knowledge: SAE reporting, PSUR/PBRER, and device vigilance procedures.
  • Labeling and promotional review expertise, including local/regional labeling requirements and translation workflows.
  • Proficient with regulatory submission tracking tools, EDMS, eCTD publishing software and MS Office suite (Excel, Word, PowerPoint).
  • Knowledge of GxP quality systems, GMP, ISO standards (for devices), and experience preparing for regulatory inspections and audits.
  • Experience coordinating global submissions and managing regional submission variations and dossiers.
  • Project management skills for multi-stakeholder submission timelines, milestone tracking and risk mitigation.
  • Familiarity with clinical trial regulatory submissions and safety reporting processes.

Soft Skills

  • Excellent cross-functional collaboration and stakeholder management across R&D, quality, manufacturing, clinical and commercial teams.
  • Strong analytical thinking and problem-solving to interpret regulations and apply them to product-specific scenarios.
  • Meticulous attention to detail and high standards for documentation quality and regulatory compliance.
  • Effective written and verbal communication with internal teams and regulatory authorities.
  • Ability to prioritize multiple regulatory projects in a fast-paced environment and meet tight deadlines.
  • Adaptability to changing regulatory landscapes and ability to rapidly incorporate new guidance into plans.
  • Persuasive negotiation and influence skills when advocating regulatory positions or timelines.
  • Proactive mindset with a focus on continuous improvement and process optimization.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in life sciences, pharmacy, chemistry, biology, biomedical engineering, or related scientific discipline.

Preferred Education:

  • Advanced degree (MS, MSc, PharmD) or certification in Regulatory Affairs (RAPS/Regulatory Affairs Certification) or related postgraduate training.

Relevant Fields of Study:

  • Regulatory Affairs
  • Pharmacy / Pharmaceutical Sciences
  • Chemistry / Biochemistry
  • Biomedical Engineering
  • Life Sciences / Biology

Experience Requirements

Typical Experience Range:

  • 2–7 years of progressive regulatory affairs experience in pharmaceuticals, biologics or medical devices, including hands-on submission experience.

Preferred:

  • 5+ years of direct regulatory submission experience with proven successful filings (IND, NDA, MAA, 510(k), or equivalent), prior experience interacting with FDA/EMA, and demonstrated project leadership on multi-regional submissions.
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