A Regulatory Affairs Associate is responsible for developing and implementing regulatory strategies. They guide activities to meet regulations, direct the regulatory submission process and approval procedures, and write regulatory documents for submissions to regulatory agencies. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Regulatory Affairs Associates.

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Main Responsibilities of Regulatory Affairs Associate

The following list describes the typical responsibilities of a Regulatory Affairs Associate:

Adjust

Adjust effectively to work within new work structures, processes, requirements, or cultures.

Apply

Apply / renew permits and products in preparation for international exportation.

Assist in

• Assist in defining regulatory strategies and plans to optimize commercialization.

• Assist in recall and adverse event reporting activities.

• Assist in regulatory planning and strategy for new and existing products.

• Assist in the development of relevant data to complete regulatory submissions.

• Assist in the preparation and submission of medical device applications.

• Assist in the preparation of business proposals, presentations, and marketing materials.

• Assist in the preparation of packages for regulatory agencies and meetings with the agencies.

• Assist with preparation for and participate in regulatory agency audits.

Attend

Attend cross-functional meetings as the Regulatory representative for the product.

Build

Build and maintain positive relationships internally and externally.

Communicate

• Communicate effectively verbally and in writing.

• Communicate effectively with Peers & Functional Partners.

• Communicate with diverse audiences and personnel.

Compile

Compile, submit and monitor End-Use form / Farm Profile for vaccines under Special Registration.

Conduct

• Conduct impact assessment of key guidance documents and regulations.

• Conduct regulatory assessment of changes for impact to marketed devices.

Contribute to

Contribute to the creation and promotion of an environment of teamwork and empowerment.

Coordinate

• Coordinate and manages the QMS Training and QMS Document Control program for the company.

• Coordinate and monitor vaccine sample submission for routine analysis and initial registration.

• Coordinate and provides support in implementing various RPI projects.

• Coordinate communication and regulatory reviews for China, including translation as needed.

• Coordinate product license / registration submissions.

• Coordinate with Head of Regulatory Affairs Head (PBG GRA) on product recall.

• Coordinate with the site timelines to respond to FDA deficiency letter.

Create

• Create and manage project plans and timelines.

• Create / verify leaflets and brochures.

Develop

• Develop accurate submission containing all required elements.

• Develop and implement regulatory strategies for applicable products in a variety of geographies.

• Develop and Maintain Key Relationships.

• Develop and maintain knowledge of regulatory requirements independently and with line manager.

• Develop and / or identify new work processes and the improved utilization of resources within groups.

• Develop global regulatory strategies and update based upon regulatory changes.

Direct

Direct the regulatory submission process.

Ensure

• Ensure compliance of assigned dossiers.

• Ensure compliances with applicable laws and regulations including company policies.

• Ensure compliance with all Good Manufacturing (GMP) and Good Documentation (GDP) practices.

• Ensure final document components are electronically archived.

• Ensure full compliance / inspection-audit readiness as established by internal SOPs.

• Ensure product strategies, submission and approval.

• Ensure regulatory data is maintained in electronic systems.

• Ensure that regulation-driven requirements are captured and addressed throughout product development.

• Ensure the proper data is developed.

Establish

• Establish and maintain collaborative relationships while driving solutions to meet business needs.

• Establish, and maintain, strong relationship with the regulatory authorities.

Evaluate

Evaluate regulatory risks of corporate policies.

Execute

Execute and manage technical and scientific regulatory activities.

Facilitate

Facilitate meetings and participate in negotiations with regulatory authority as necessary.

File

• File necessary paperwork to FDA for renewal of establishment and NDC numbers.

• File premarket applications to regulatory agencies such as FDA, Health Canada and EU Notified Body.

• File products with the FDA.

Foster

Foster Collaboration and Teamwork.

Handle

• Handle regulatory submission and approval procedures of new drugs and generic drugs.

• Handle submission to respective regulatory agencies of all post approval variations.

Help

Help with other team functions as required.

Hold

Hold meeting(s) with customers affected by the deficiency letter if requested.

Identify

• Identify submission or regulatory activity issues and resolves regulatory questions.

• Identify issues and help form hypotheses and solutions to address client questions.

• Identify obstacles and work with manager / mentor to develop solutions for the team.

Influence

Influence internal and external stakeholders for successful regulatory outcomes.

Initiate

Initiate corrective action as required.

Interpret

• Interpret and apply regulatory requirements.

• Interpret Canadian regulations, guidelines and policies.

Investigate

• Investigate and solve problems that impact work processes and personnel across departments.

• Investigate complaints and determine reportability.

Keep up to date on

Keep up to date information on submission and pre-submission requirements and options.

Lead

• Lead crisis management program development and implementation.

• Lead with Integrity and Respect.

Liaise with

• Liaise internally and externally with regulatory agencies.

• Liaise with regulatory agency to ensure prompt regulatory approvals.

Log

Log and track all customer request into our customer portal.

Maintain

• Maintain compliance of associated regulatory documentation systems.

• Maintain compliance to global quality system needs.

• Maintain high level of knowledge on the science of products within defined portfolio.

• Maintain necessary record-keeping on regulatory related issues.

• Maintain product registration renewals, including management of registration databases.

• Maintain regulatory files / databases and chronologies in good order.

Manage

• Manage client portfolio for regulatory submissions.

• Manage new product development.

• Manage the authorship and publication of electronic submissions.

Moderate

Moderate to high responsibility for information and or services.

Monitor

• Monitor costs of projects and resources within a department.

• Monitor emerging regulatory issues and identify solutions.

• Monitor regulatory trends that could impact portfolio.

Negotiate

Negotiate with regulatory authorities.

Obtain

Obtain all permits and licenses.

Participate

• Participate in DRA strategy meetings.

• Participate in Regulatory Affairs department initiatives.

Perform

• Perform artwork verification on post production product.

• Perform follow-ups to insure that the regulatory requirements needed to a study start are met.

• Perform Internal audits, as required.

• Perform submissions to pre-clearance agencies as required.

Plan

• Plan and conduct effective meetings.

• Plan and conduct submission team meetings.

• Plan and negotiate publishing timelines with the teams.

Prepare

• Prepare and distributes Material Safety Data Sheets (MSDS) for customers.

• Prepare and maintain labelling to support MAAs and other post-licensing activities.

• Prepare and maintains regulatory files and tracking databases.

• Prepare and manage regulatory registration filings across product lifecycles.

• Prepare and peer review labelling, product monographs and marketing materials.

• Prepare and submit regional device registrations and listings.

• Prepare a wide range of product registration, submissions for drugs and Natural Health Products.

• Prepare documentation and submissions for certifying agencies such as NSF / DfE and Ecologo.

• Prepare Investigation Reports.

• Prepare raw material breakdowns to prepare an accurate ingredient list of finished products.

• Prepare supporting material for RPI staff on regulatory policy topics.

Prioritize

Prioritize own work and manage project schedule to meet delivery deadlines.

Provide

• Provide compliance support to BU as needed.

• Provide impact / assessments regarding changes in CMC or clinical drug development.

• Provide input for product development and planning throughout the product lifecycle.

• Provide input on training materials, and may assist in training junior team members.

• Provide internal and client regulatory guidance on feasibility and filling requirements.

• Provide progress of work-plans and the status of key project deliverables.

• Provide project management support as needed to improve client experiences.

• Provide regulatory guidance including strategies for new products.

• Provide regulatory guidance to customers who do not have the level of sophistication and knowledge.

• Provide Regulatory Guidance to entry level employees.

• Provide regulatory updates and impact to products and labeling to BU.

• Provide statistical analysis for clinical studies, protocols, and reports.

• Provide strategic guidance for product development and planning throughout the product lifecycle.

• Provide supporting documents for the government / Hospital Authority tender applications.

• Provide support in the review of promotional and non-promotional materials.

• Provide training to site and BU managers.

Purpose

Purpose of internal / external contacts regularly related to complex matters.

Receive

Receive monthly report to update the spreadsheet from Regulatory Life Cycle Management.

Recommend

• Recommend regulatory strategies and tactics to deliver optimal HC approvals of CTAs.

• Recommend solutions to mitigate risk of proposed regulatory strategies.

Records

Records and Files Management.

Recruit

Recruit, develop and mentor regulatory professionals.

Represent

• Represent regulatory affairs on internal project teams.

• Represent regulatory on cross-functional meetings to provide regulatory assessment.

Resolve

• Resolve complex issues relating to submissions.

• Resolve regulatory issues raised internally, or by government agencies.

Respond to

Respond to Food and Drug Administration (FDA) Deficiency.

Review

• Review advertising to ensure compliance with appropriate regulations and internal policies.

• Review and approve Engineering Change Orders in accordance with regulatory requirements.

• Review and approve final submission.

• Review and approve labelling and formulations for acceptability.

• Review and approve promotional materials.

• Review and approves artwork circulations and remains current on all labeling standards & policies.

• Review and approves product artwork and specification.

• Review and provide global regulatory impact assessments for changes.

• Review and publishing of Annual Reports.

• Review and update Regulatory Affairs Department Standard Operating Procedure's.

• Review and write outlines of production, as well as other special outlines.

• Review / approve product bill of materials (BOM) and update to approve.

• Review artwork changes from a regulatory compliance standpoint.

• Review artwork for fill weight claims, ingredients and regulatory issues.

• Review Certificates of Analysis, Certificates of Conformance, Inspection Reports.

• Review Change Controls and provide input into regulatory filing assessment.

• Review, correct and approve the artworks.

• Review documents to ensure accuracy of text, layout, and references.

• Review, edit and proofread regulatory documentation.

• Review formulas either using the Ithos IIN system or the PCPC International Raw Material Database.

• Review labelling and formulations for acceptability.

• Review marketing material to determine alignment with regulated product claims.

• Review of change control documents.

• Review product labeling and promotion materials to assure compliance with regulations and approvals.

• Review validation protocols.

Run

Run training and awareness sessions on labeling processes and expectations to stakeholders.

Schedule

Schedule team meetings, draft agendas and capture and distribution meeting summary.

Seek

Seek guidance from other team members to enhance regulatory knowledge.

Summarize

Summarize requirements of the countries so one submission can be built to support all countries.

Support

• Support corporate change management initiatives within the department.

• Support end-to-end regulatory compliance of products.

• Support in-house testing of products.

• Support in the maintenance of global and local regulatory trackers and databases.

• Support in the preparation of clinical trial application.

• Support Labeling operations and systems.

• Support maintenance of Global Labeling SharePoint page.

• Support other regulatory intelligence activities as needed.

• Support RA team on assigned projects.

• Support searches of regulatory intelligence sources to support senior RPI staff.

• Support the Health Authority interface throughout the development and lifecycle of a product.

• Support the overall strategic.

• Support the preparation and other activities during an FDA inspection or other audit.

• Support the preparation of regulatory submissions for investigational medicinal products.

• Support the process of new product licensure.

• Support the publishing and submission of documents to regulatory authorities.

• Support the remainder of the Oncology and Anti-infectives team as required.

• Support the Virology team as required.

Track

• Track regulatory changes, perform impact assessment, and guide activities to meet new regulations.

• Track and communicate critical attributes of projects to ensure accountability and efficiency.

Troubleshoot

Troubleshoot errors and system performance and issues.

Understand

• Understand Business and Financial Environment.

• Understand the origin and reasoning behind key policies, practices and procedures.

Update

Update WWMAs for Safety Reports using the WWMA report from regulatory reports.

Utilize

• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results.

• Utilize technical regulatory skills to propose strategies on complex issues.

Work

• Work across Regulatory and Quality functions ensuring timely advice and insight.

• Work in a safe manner collaborating as a team member to achieve all outcomes.

• Work with the team to synthesize findings and refine recommendations.

Write

• Write and edit technical documents.

• Write new Standard Operating Procedures' as needed.

• Write regulatory documents for submissions to FDA and other regulatory agencies, as needed.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Regulatory Affairs Associate:

1. Regulatory Affairs

2. MS Excel

3. Project Management

4. FDA

5. Chemistry

6. MS Powerpoint

7. MS Word

8. Pharmacy

9. Life Sciences

10. Microsoft Office

11. MS Outlook

Most In-demand Soft Skills

The following list describes the most required soft skills of a Regulatory Affairs Associate:

1. Written and oral communication skills

2. Organizational capacity

3. Interpersonal skills

4. Analytical ability

5. Attention to detail

6. Problem-solving attitude

7. Time-management

8. Detail-oriented

9. Planning

10. Teamwork

11. Leadership

12. Integrity

13. Strategic thinking

14. Accountable

15. Assessment

16. Attention to detail with accuracy

17. Collaborative

18. Organized

19. Self-starter

20. Agile