Main Responsibilities and Required Skills for Regulatory Affairs Manager
A Regulatory Affairs Manager is a professional who provides regulatory assessments to businesses. They review protocols and reports to support regulatory compliance and submissions and identify and assess regulatory risks. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Regulatory Affairs Managers.
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Main Responsibilities of Regulatory Affairs Manager
The following list describes the typical responsibilities of a Regulatory Affairs Manager:
Analyze
Analyze and interpret complex regulations.
Analyze possible solutions using standard procedures.
Assess
Assess and communicate impact of relevant regional regulations / standards in local market.
Assess impact on programs.
Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
Assist in
Assist in preparation of documentation needed for regulatory submissions.
Assist in supervision and training of regulatory staff as required.
Assist Product Development department in maintaining product safety / electrical / EMC compliance.
Assist quality management system audits, including regulatory parts of MDSAP and EU.
Assure
Assure all audits so that organization and government standards on products / processes are met.
Assure compliance with Baxter and external standards.
Attend
Attend all applicable meetings as regulatory representative.
Build
Build and maintain effective relationship with authorities and associations.
Build and manage a committed, accountable organization.
Build strong regulatory relationships with Health Canada and other external stakeholders.
Collaborate
Collaborate across boundaries to create cross business opportunities.
Communicate
Communicate application progress to internal stakeholders.
Communicate early regulatory input into early phase Discovery projects.
Communicate regulatory input into early phase Discovery projects.
Communicate with diverse audiences and personnel.
Compile
Compile, prepare, review and submit regulatory submission to authorities.
Complete
Complete regulatory approval process and gain product licenses.
Conduct
Conduct post market surveillance activities on new products.
Conduct timely and candid performance evaluations.
Consult
Consult on ongoing basis on related issues with management team.
Consult with PI team regarding strategic planning around clinical research portfolios.
Contribute to
Contribute to the effective running of departmental and cross functional project teams.
Contribute with regulatory support during health authority site inspections.
Coordinate
Coordinate compliance committee meetings.
Coordinate department or clinic compliance with a moderate level of guidance.
Coordinate development of labeling material with Quality Assurance Officer.
Coordinate regulatory meetings by assisting with agenda, minutes or action items.
Create
Create a sustainable infrastructure and environment that enables growth.
Create immediate to long-range plans to carry out objectives established by top management.
Determine
Determine submission and approval requirements.
Develop
Develop and maintain strong and effective relations with internal / external personnel.
Develop and maintain the Core Data Sheet and lead global labeling team meetings.
Develop and maintain tracking system for registration procedure to ensure clear registration status.
Develop global regulatory strategies for new and modified medical devices.
Develop, implement and manage appropriate SOPs and systems to track and manage product-associated.
Develop new regulatory policies, processes and SOPs and train key personnel on them.
Develop realistic action plans.
Direct
Direct global clinical and pre-clinical regulatory strategies.
Direct IND and NDA coordination and preparation.
Directs
Directs the operations of regulatory compliance programs.
Discuss
Discuss and challenge issues and negotiate solutions in the best interests of the company.
Drive
Drive local processes to ensure compliance and corporate harmonization.
Drive product change assessments and define regulatory impact of product changes in global markets.
Drive Regulation change through participation of Industry Association Taskforce.
Educate
Educate and train others on Global Regulatory Systems, Processes, and Procedures as applicable.
Encourage
Encourage open exchange of ideas and knowledge.
Ensure
Ensure alignment with the country and regional business strategies.
Ensure compliance of labeling materials with the Generics Law and other relevant laws.
Ensure compliance with all internal and external requirements and procedures and may suggest.
Ensure compliance with product postmarketing approval requirements.
Ensure compliance with regulations and company's policies / guidance / SOPs.
Ensure maintenance of in-line products and support new business opportunities.
Ensure products are maintained and meet internal and external compliance requirements.
Ensure regulatory compliance.
Ensure regulatory compliance in commercial activities.
Ensure regulatory support to GMP inspections if required.
Ensure that labeling, advertising and promotional activities meet applicable regulatory requirements.
Ensure the local label creation and packaging development.
Ensure timely submissions of post-approval commitments.
Ensure to file new product registration and update the current registration file in timely manner.
Establish
Establish and maintain relations with KOLS (individual meetings, conferences, congresses).
Establish operational objectives and work plans, and delegates assignments to subordinates.
Evaluate
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Exercise
Exercise good and ethical judgment within policy and regulations.
Facilitate
Facilitate FDA pre submission meetings.
Facilitate the availability of SDS to cross functional partners.
Follow up
Follow up the registration plan assuring the accomplishment of the target dates.
Forecast
Forecast future needs including human and material resources and capital expenditures.
Help
Help define the regional regulatory strategy for development or marketed products.
Hire
Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback.
Hire, coach, mentor and develop staff.
Identify
Identify and assess regulatory risks associated with product development.
Identify anticipated governmental inspections and understand the role of Abbott Regulatory Personnel.
Identify risks and lead remediation plan development.
Implement
Implement and streamline documentation and tracking systems.
Implement the submission and archive appropriately.
Interface with
Interface directly with Boards of Health, including scientific reviewers, administrative staff,.
Interface with a variety of management levels including senior management on significant matters.
Involve
Involve in regulation influence activities.
Keep
Keep good touch with HA to ensure registration go smoothly in China.
Keep up-to-date with changes in regulatory legislation and guidelines.
Lead
Lead a team of 6+ regulatory affairs specialists.
Lead regulatory operations for the assigned products in China.
Lead team to carry on innovative projects and maintanance.
Lead the development, implementation and review of the Project-Specific Plans.
Leverage
Leverage diversity of people and thinking to create a competitive advantage.
Liaise with
Liaise between Regulatory Affairs and the Science team.
Liaise closely with US regulatory staff to facilitate global registrations where appropriate.
Liaise with Gilead's document authoring departments and product experts.
Liaise with government to ensure regulatory compliance.
Maintain
Maintain adequate standard work processes to support the technical regulatory team.
Maintain high level of product knowledge within defined portfolio.
Maintain product license in compliance with market supply, and local authority expectations.
Maintain regulatory files and tracking databases as required.
Make
Make the difficult decision.
Manage
Manage approval requirements per the Private Management Act ("PMA”).
Manage budget and resources.
Manage / directs individuals working on submissions to meet corporate.
Manage global pre-market and post-market submission activities.
Manage, mentor and coach regulatory professionals in their development.
Manage new product development timelines.
Manage the Regulatory Affairs function for a significant business segment.
Mentor
Mentor Regulatory Managers and guide direct reports in carrying out responsibilities.
Monitor
Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
Monitor and timely reflect the risks of MOH local legislation and regulatory normative changes.
Monitor the financial resources of the unit in order to meet plans and budget.
Monitor trade association positions for impact on company products.
Motivate
Motivate, develop and reward team a high performance culture, aligned with HR policies and practices.
Negotiate
Negotiate internally and externally with regulatory agencies.
Notify
Notify and interact with agencies when required.
Obtain
Obtain approval / complete notification to meet launch timeline.
Offer
Offer alternative solutions and risk levels with business consequences as needed.
Order
Order, translate, compile and prepare registration.
Participate
Participate in bid defense presentations and meetings.
Participate in MDSAP audit as a regulatory SME as required.
Participate in protocol writing.
Perform
Perform other duties as assigned by management.
Perform other related duties and responsibilities, on occasion, as assigned.
Perform regulatory responsibilities related to label and packaging development . (.
Perform risk assessment or analysis.
Perform vigilance activities.
Prepare
Prepare all the SOP associated with the MDSAP and ISO13485 registration process and audit.
Prepare and deliver effective presentations for external and internal audience.
Prepare and run the actions to address.
Prepare and validate registration dossier to ensure fully meet Chinese regulations and guildlines.
Prepare / format the dossier to ensure it meets local requirements.
Prepare, submit and manage submissions for TPD product licenses.
Prioritize
Prioritize regulatory projects and site registration timeline.
Prioritize regulatory projects in line with business needs.
Propose
Propose solutions to identified issues and implement.
Provide
Provide accurate, frequent, and constructive feedback to subordinates, peers, and leaders.
Provide advice about regulations to manufacturers.
Provide expert regulatory input to strategic decision making.
Provide feedback, coaching and work direction to team leaders and team members.
Provide guidance on organization and management of regulatory files and records.
Provide guidance to faculty regarding compliance, funding and research support resources.
Provide input to Regulatory Senior Management teams.
Provide leadership by communicating and providing guidance towards achieving department objectives.
Provide leadership, coaching and career development.
Provide ongoing training, support and development team member of the Regulatory Affairs Department.
Provide RA assessment and strategy for new business developments and projects.
Provide RA budget plan to Finance and manages all RA related expenses.
Provide regulatory assessments for manufacturing, design changes, and validation activities.
Provide regulatory input for product recalls and recall communications.
Provide regulatory support for Special Access Programs.
Provide regulatory support to global, regional and local new product development activities.
Provide regulatory support to Medical and Marketing team as well as other company personnel.
Provide strategic input and technical guidance on regulatory requirements to development teams.
Provide strong regulatory leadership, direction and support for regulatory strategies.
Provide Submission Management support to plan, track, and manage complete regulatory submissions.
Provide support to local procedures development and update.
Provide targeted career coaching and feedback.
Provide technical leadership to business units.
Recruit
Recruit, develop and coach direct reports for performance.
Recruit, develop and mentor regulatory professionals ensuring an effective succession plan.
Recruit, train and manage a team of Regulatory Affairs Associates.
Renew
Renew and revise the existing product license to ensure all are valid and compliance with regulation.
Report
Report adverse events to regulatory agencies and internal stakeholders.
Represent
Represent or lead the RA function on assigned cross-functional project teams.
Represent regulatory on cross functional initiatives.
Represent the University's interests in administrative and judicial proceedings.
Request
Request and maintain SDS's for finished products.
Review
Review and approve advertising, promotional items and labeling for regulatory compliance.
Review and approve test protocols to support regulatory submissions.
Review promotional materials.
Review protocols and reports to support regulatory compliance and submissions.
Set up
Set up the local registration strategy / plan for responsible products.
Shape
Shape regulations and standards to create favorable regulatory environment to the business.
Stay current on
Stay current on all regulatory, market, and industry developments.
Supervise
Supervise the registration of marketed product.
Support
Support design and execution of local acceptability studies to support reimbursement applications.
Support digital transformation.
Support efforts to ensure compliance with all aspects of the federal and state laws and regulations.
Support end-to-end regulatory compliance of products in remit.
Support EU representatives in their creation of CE / IVD Technical Files.
Support global initiatives (e.g. Codex).
Support global regulatory affairs project management for shared projects and initiatives.
Support global regulatory registration representatives for product global registration activities.
Support Key market RA team on global registrations.
Support line manager on budget planning and monitoring in daily work.
Support Marketing team in applying advertisement licenses & detail aid material printing permits.
Support meaningful development activities.
Support the development and continual improvement of internal regulatory processes.
Support the DRA in conducting and executing due diligence processes.
Support the extension work on demand of NMPA (e.g. guideline updates).
Support the Think Quality Policy and Quality Management System.
Support the Virology team as required.
Support to the management of the quality system.
Take
Take action in a timely manner, with urgency or caution as appropriate, but always in a planful way.
Take appropriate accountability for failure.
Take part in the development of processes for business related to regulatory transparency reporting.
Understand
Understand and comply with local pharmaceutical / nutrition regulations and guidance.
Understand and share current updates in regulations / new guidelines / circulars published by DAV.
Understand the use of team / web sites, IT tools and systems for the business area.
Uphold
Uphold the company's core values.
Use
Use Gilead systems for planning, preparing, tracking and storing submissions to regulatory agencies.
Utilize
Utilize technical regulatory skills to propose strategies on complex issues.
Work with
Work with cross-functional teams.
Work with people from various disciplines and cultures.
Write
Write and edit technical documents.
Write and update technical files.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Regulatory Affairs Manager:
Continuous Sitting for Prolonged Periods
Medical Device Industry
Life Science
General Office Demands
Medical Device
MS Office
Pharmacology
Technical Area
Most In-demand Soft Skills
The following list describes the most required soft skills of a Regulatory Affairs Manager:
Written and oral communication skills
Interpersonal skills
Organizational capacity
Analytical ability
Attention to detail
Problem-solving attitude
Planning
Leadership
Negotiation
Influencing
Strategic thinking
Self-motivated
Teamwork
Work independently with little direction
Accountable
Integrity
Organized
Presentation
Multi-task
Proactive
