Main Responsibilities and Required Skills for Regulatory Affairs Specialist
A Regulatory Affairs Specialist is responsible for reviewing and approving products and labeling for regulatory compliance. They perform a regulatory assessment and recommendation. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Regulatory Affairs Specialists.
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Main Responsibilities of Regulatory Affairs Specialist
The following list describes the typical responsibilities of a Regulatory Affairs Specialist:
Apply
Apply business and regulatory ethical standards.
Apply strategic thinking / planning for process improvements / agency data simplification.
Apply subject matter knowledge in the area of Regulatory Affairs.
Apply technical know-how to regulatory product chemistry related projects.
Assemble
Assemble technical information, in order to fulfill registration requirements.
Assess
Assess and communicate impact of relevant regional regulations / standards in local market.
Assess emerging Regulations against Quality System.
Assess regulatory product changes to determine impact on on-market.
Assist in / Assist with
Assist assessing and reporting adverse events for medical device and drugs.
Assist in creating technical dossiers for product registrations in other markets (e.g. EU).
Assist in Regulatory SOP development and review.
Assist in SOP development and review Provide regulatory input to product lifecycle planning.
Assist in the development of regional regulatory strategy.
Assist journeyman technicians.
Assist with all pre-audit preparations.
Assist with complaints handling and product labelling / claims activities.
Assist with device recall activities.
Assist with FDA 510 (k) , Japanese and European submissions.
Assist with FDA facility inspections, Notified Body Audits and other governmental inspections.
Assist with label development and review for compliance before release.
Carry out
Carry out duties in compliance with established business policies.
Communicate
Communicate business related issues or opportunities to next management level.
Communicate with business partners in order to track, complete, and distribute submissions.
Complete
Complete directed assignments.
Conduct
Conduct informational or training sessions for stakeholders.
Conduct research to determine efficiency and effectiveness of managerial policies and programs.
Consult
Consult with SMD management and RA CMC managers for issues.
Contribute to
Contribute to the development and functioning of the crisis / issue management program.
Contribute towards the development of the Regulatory Strategy.
Coordinate
Coordinate clinical Investigations as needed, and draft the necessary clinical documentation.
Coordinate internal operations teams to ensure the successful and timely execution of field trials.
Coordinate special access program involving approvals, tracking, and final product release.
Coordinate submission component authoring (including post-approval CMC changes).
Create
Create and maintain an electronic or hard copy filing system for organizational records.
Create, reviews and approves engineering changes.
Define
Define the US regulatory strategy.
Develop
Develop and execute global plans and regulatory submission deliverables for sustaining variations.
Develop and maintain a good working relationship with internal and external stakeholders.
Develop and maintain regulatory affairs department procedures and process improvements.
Develop and update training resources on materials review process.
Develop internal procedures and tools.
Develop internal procedures to ensure continuous compliance with all regulatory requirements.
Develop international strategies for regulatory approval of company products.
Develop overall timelines and plans to ensure regulatory requirements are.
Develop quality assurance plans by conducting hazard analyses.
Develop white papers and presentation slides outlining policy positions and strategy.
Ensure
Ensure implementation of new regulations / guidance within legal deadlines.
Ensure maintenance of in-line products and support new business opportunities.
Ensure of confidentiality of the documents and registration processes.
Ensure personal compliance with applicable company policies and procedures.
Ensure product safety issues and product associated events are reported to regulatory agencies.
Ensure product safety issues and product-associated events are reported to regulatory agencies.
Ensure product safety issues and products associated events are reported to regulatory agencies.
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
Ensure relevant EU MDD requirements are met, as required.
Ensure that all resources needed to do so are available, if applicable.
Escalate
Escalate any doubts or uncertainties to their supervisor and / or manager.
Establish
Establish and maintain good relationships with agency personnel.
Establish and maintain regulatory information systems both electronically and hard copy.
Establish priorities of work assignments.
Establish procedures to identify and implement new ways of working across sites and geographies.
Evaluate
Evaluate and maintain current regulatory policies, processes, procedures.
Evaluate import / export requirements.
Evaluate various alternatives.
Execute
Execute and manage technical and scientific regulatory activities.
Execute facility submission plan for Americas region to maintain access for Accuray's products.
Foster
Foster Collaboration and Teamwork.
Handle
Handle day to day work challenges confidently.
Handle detailed tasks and prioritize them.
Handle the control of packaging components artworks developed by labeling coordinator.
Implement
Implement submission templates.
Initiate
Initiate and / or maintain schedule for projects and project milestones.
Interact with
Interact with Ministry of Health and technical KOLs when needed.
Interface with
Interface directly with U.S. Food and Drug Administration (FDA) and other regulatory agencies.
Interface directly with FDA and other regulatory agencies.
Interface directly with regulatory agencies as needed.
Interface directly with U.S. Food and Drug Administration (FDA) and other regulatory agencies.
Interface with governmental agency on projects / products as identified by the manager.
Interpret
Interpret and apply emerging regulatory requirements to ongoing work.
Keep
Keep up to-date with US, EU and other global regulatory guidelines.
Lead
Lead regulatory submissions strategy and update strategy based upon regulatory changes.
Lead with Integrity and Respect.
Maintain
Maintain a clean and safe work environment as per company requirements.
Maintain a positive relationship with internal and external regulatory contacts.
Maintain approvals / licenses / authorizations for existing marketing authorizations.
Maintain a thorough knowledge of current QSR and ISO requirements as they apply.
Maintain awareness, excellent comprehension and appropriate application of relevant regulations.
Maintain compliance and integrity of study trial master file in paper / electronic formats.
Maintain current awareness of all regulatory guidelines.
Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
Maintain detailed knowledge on the subject of ISO 13485 and QSR requirements.
Maintain our product renewal calendar and keep up to date with changes to the regulatory landscape.
Maintain proficiency in U.S. regulatory requirements.
Maintain regulatory databases and applications to ensure all systems are accurate.
Maintain regulatory files and tracking databases on SharePoint site.
Maintain working knowledge of computer software packages including MS Word,.
Manage
Manage all the regulatory surveys applicable to US regulations.
Manage processes involved with maintaining annual licenses.
Manage the process for obtaining International certificates and Gold Seal Letters.
Monitor
Monitor applications under regulatory review.
Monitor emerging issues and identify solutions.
Monitor impact of changing regulations on submission strategies.
Outline
Outline submission and approval requirements in assigned geographies.
Oversee
Oversee product registration and delisting as appropriate (SPL, CMS).
Participate
Participate as an auditor in internal audit activities.
Participate in business meetings with potential new external partners.
Participate in FDA inspections as required.
Participate in GMP audits with the Regulatory Manager when deemed necessary.
Participate in risk benefit analysis for regulatory compliance.
Perform
Perform a Regulatory Assessment and recommendation.
Perform general duties as required by the Regulatory Manager.
Perform multiple tasks concurrently with accuracy.
Perform other duties and projects as assigned.
Perform other duties as assigned.
Perform quality control of documents provided by sites.
Perform regulatory assessment of new and changed products.
Plan
Plan and conduct meetings, create project plans and timelines, and manage projects.
Plan and organizes project assignments of substantial variety and complexity.
Prepare
Prepare and negotiate both internally and externally with various regulatory agencies.
Prepare and present reports outlining the status of the project and need for corrective actions.
Prepare and submit documentation in compliance with the Canadian Medical Device Regulations.
Prepare annual reports and renewal submissions to various regulatory jurisdictions.
Prepare, compile & review Regulatory / Quality documents to support submissions to various markets.
Prepare due diligence reports or other related documents.
Prepare, file and manage regulatory submissions for class III and IV medical.
Prepare samples and documents then submits for product registration & notification in China.
Prepare submissions and reports for assigned products.
Prepare US submissions and International submissions.
Propose
Propose improvements to methods, systems and procedures.
Provide
Provide guidance and expertise.
Provide local expertise to internal teams during initial and on-going project timelines planning.
Provide mentoring and leadership to Regulatory Specialist I and II team members.
Provide regulatory guidance for product's requirements.
Provide regulatory guidance to customers who do not have the level of sophistication and knowledge.
Provide regulatory input to product lifecycle planning.
Provide regulatory updates and impact to products and labeling.
Provide support for product recalls and recall communications.
Provide support to currently marketed products as necessary.
Provide support to currently-marketed products as necessary.
Provide update and maintain status of product registrations and notifications.
Remain current on
Remain current on all applicable regulations as well as company labeling standards and policies.
Represent
Represent RA Operations on Regulatory sub teams as necessary, escalate timeline issues.
Represent the business in interactions with regulatory authorities.
Respond to
Respond to FDA Deficiency Letters.
Respond to RA information requests.
Review
Review and analyze documentation.
Review and approval of label changes, advertising and promotional items.
Review and approve advertising and promotional items to ensure regulatory compliance.
Review and approve ingredients and labeling materials for Drugs and Medical Devices.
Review and approve labeling changes to ensure compliance with regulatory requirements.
Review and approve labeling, training, promotional, and advertising material.
Review and approve product labels, advertising, and promotional items for regulatory compliance.
Review and approves Advertising and Promotional materials.
Review and approve test protocols to support regulatory submissions.
Review and input into regulatory strategy documents.
Review / approve and guide the development of advertising and promotional material.
Review, disposition and approve Engineering Change Requests.
Review each document for regulatory compliance, accepts or rejects documents.
Review, edit and proofread regulatory documentation.
Review information to relating to medical device complaints.
Review new raw materials against jurisdictional compliance.
Review of marketing material to determine alignment with regulated product claims.
Review proposed labeling for compliance with applicable global regulations.
Review protocols and reports to support regulatory submissions.
Review regulatory aspects of contracts.
Review technical documentation for regulatory compliance.
Review test reports for regulatory submissions.
Secure
Secure product license by updating CMC, CCDS and safety information.
Support
Support activities for the UK market for both NorthStar and non-NorthStar products.
Support EU MDR transition activities and maintains product technical files.
Support FIFRA 6 (a) (2) Reporting submissions as needed.
Support for external audits by clients and regulatory agencies.
Support in process improvement projects.
Support local RA team with government queries and registration documentation requirements.
Support notifiable events and investigations.
Support of initiatives within Reg CMC.
Support post market regulatory compliance activities for US / International product approvals.
Support pre-market and post-market activities for Drugs and Medical Devices in the US and Canada.
Support product safety issues and product-associated events reported to regulatory agencies.
Support special projects as needed.
Support the development and continual improvement of internal regulatory processes.
Support the product release process by reviewing and approving requests for product release.
Support the product release process or reviewing and approving requests for product release.
Support the Regulatory team with other regulatory-focused activities as required.
Train
Train appropriate personnel on regulatory procedures.
Understand
Understand and investigate regulatory history / background of class, disease /.
Understand that compliance with the Code of Conduct, as it may be amended by.
Understand the business environment and the regulatory environment in formulating strategy.
Understand the Scope of Work, timelines and deliverables for a given project.
Undertake
Undertake deputized duties as required.
Update
Update Regulatory Information System as information is acquired to support future submissions.
Update local and global systems frequently.
Use
Use of software tools for formatting of product labeling.
Use risk-based approach for prioritization of activities.
Utilize
Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results.
Utilize time management skills to effectively write, coordinate, and execute regulatory items.
Work with
Work closely with the Quality team in the areas of Vigilance, Post Market Surveillance and PSURs.
Work independently and recognize when issues need to be elevated to management.
Work independently and with team members to identify and then mitigate risks / issues.
Work under limited supervision ensuring deliverable meets Abbott's internal standards.
Work with cross functional teams.
Work with governmental regulatory agencies and other third-party accrediting bodies.
Work with people from various disciplines and cultures.
Work with project team to develop key deliverables that need to be tracked and managed.
Write
Write regulatory documents as needed.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Regulatory Affairs Specialist:
Operations
Biology
Pharmacy
Microbiology
Medical Technology
Pharmacology
Math
Immunology
Quality Assurance
Regulated Industry
Medical Products
Scientific Affairs
Medical Devices
PMA Supplements
Submissions
International Medical Device Regulations
Life Sciences
Regulatory
Us Device Regulations
ISO 13485
MS Outlook
MS Office
Pharmaceutical Industry
PMA
Most In-demand Soft Skills
The following list describes the most required soft skills of a Regulatory Affairs Specialist:
Written and oral communication skills
Attention to detail
Organizational capacity
Interpersonal skills
Problem-solving attitude
Communicate at multiple levels in the organization
Analytical ability
Follow-up
Leverage and / or engage others to accomplish projects
Time-management
Exercise judgment
Detail-oriented
Team player
Work independently with little direction
Multi-task
Accurate
Effectively manage multiple projects and priorities
Organized
Presentation
Negotiating
Adaptable to changes
Quick learner
Self-motivated
