REGULATORY AFFAIRS SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: Dec 12, 2025 - The Regulatory Affairs Professional demonstrates expertise in interpreting and applying national and international regulatory requirements to ensure product compliance across all development stages. This role involves strong skills in compiling and managing regulatory submissions, analyzing technical data, and communicating effectively with regulatory bodies. The individual also possesses critical thinking, attention to detail, and project management abilities to support timely approvals and successful market access.

Essential Hard and Soft Skills for a Standout Regulatory Affairs Resume
  • Regulatory Submissions
  • Regulatory Writing
  • Compliance Management
  • FDA Regulations
  • EMA Regulations
  • ICH Guidelines
  • Quality Systems
  • Clinical Trial Regulations
  • Risk Management
  • Labeling Review
  • Attention Detail
  • Communication
  • Analytical Thinking
  • Problem Solving
  • Time Management
  • Stakeholder Collaboration
  • Adaptability
  • Ethical Judgment
  • Organization
  • Decision Making

Summary of Regulatory Affairs Knowledge and Qualifications on Resume

1. BA in Biology with 2 years of Experience

  • Experience in Regulatory Affairs or in relevant areas.
  • Comfortable using digital platforms and data processing and project management skills are welcome (Access, Excel, Macros).
  • Ability to thrive in a complex and fast-paced environment.
  • Able to lead, learns quickly and demonstrates initiative.
  • Great motivation to get results, works well in a dynamic team environment.
  • Must have rigor and organization.
  • Must have openness and flexibility.

2. BS in Biomedical Engineering with 3 years of Experience

  • Previous experience in Regulatory Affairs.
  • Advanced English for conversation and writing.
  • Experience in the registration process of medical products of all ANVISA risk classes (I, II, III and IV).
  • Knowledge of the Domain of RDC 185/01 and related regulations.
  • Knowledge of the Electromedical Certification process for health products.
  • Excellent command of Excel, Word and PowerPoint.
  • Ability to communicate with people outside the organization, represent the organization to clients, ministers of health, government and other external sources.

3. BS in Chemistry with 4 years of Experience

  • Experience in RA, preferably in a clinical-stage pharmaceutical or biotechnology company.
  • Experience performing electronic review of published submissions.
  • Knowledge of global regulatory health authority requirements for submissions.
  • Experience driving life-cycle submissions.
  • Understanding of regulatory and quality compliance requirements.
  • Strong organizational, analytical, and problem-solving skills.
  • Proficient in using Microsoft Word, Excel, Project, and Adobe Acrobat Professional.
  • Experience using an EDMS system, particularly Veeva Regulatory Information Management (RIM) Suite.
  • Strong team orientation, with excellent written and oral communication skills.
  • Able to work in conditions and meet physical requirements.

4. BS in Pharmaceutical Sciences with 6 years of Experience

  • Experience working in regulatory affairs with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting.
  • Able to prepare and review IND applications.
  • Able to communicate with the FDA and prepare for FDA inspections.
  • Able to assess risk in the conduct of clinical research.
  • Able to design tools for the regulatory management of clinical trials.
  • Able to interpret federal regulations and guidelines.
  • Able to work with all levels of a research team.
  • Mua st have a clinical research-related certification.
  • Strong familiarity with process improvement principles.
  • Excellent written and verbal communication skills.
  • Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice.
  • Ability to work collaboratively and build relationships across large organizations.

5. BS in Biochemistry with 7 years of Experience

  • Regulatory experience in the pharmaceutical industry.
  • Understanding of the development and commercial activities and cGMPs to assess technical, scientific and regulatory documentation.
  • Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC discipline.
  • Ability to maintain up-to-date knowledge of current guidance and regulations.
  • Excellent writing and organizational skills.
  • Ability to work independently.
  • Able to handle multiple projects simultaneously.
  • Ability to coordinate information from various internal and external disciplines.
  • Ability to work in a flexible environment to meet all regulatory requirements and business requirements.
  • Experience in emerging markets and regulatory filings.
  • Understanding of regulatory requirements for Sterile injectables and/or Drug-device combination product experience.
  • Knowledge and experience on EU MDR/EU MDD.

6. BA in Psychology with 6 years of Experience

  • Professional experience in the area of Regulatory Affairs, also in the area of disinfectants, cosmetics, and biocides.
  • Experience in TR REACH (KKDIK) regulation (Medical Devices, medicinal products knowledge).
  • Experience with governmental regulatory programs such as MOH and other local or international regulations.
  • Professional use of the English language, both written and oral.
  • Must have a track record of exposure to relevant regulatory agencies.
  • Strong familiarity with the Hazard communication side (MSDS, labels, GHS).
  • Good problem-solving skills.
  • Demonstrated grasp of business and regulatory processes.
  • Ability to work independently under general direction.

7. BA in Environmental Science with 5 years of Experience

  • Excellent interpersonal and communication skills.
  • Proven ability to interpret the impact of new legislation relevant to cosmetic, food, or food supplement products in International markets.
  • Understanding of the regulatory environment for cosmetics and/or food/food supplements.
  • Project Management experience, with the ability to change priorities and work to a short deadline.
  • Must have visible passion and dedication for solving complex problems.
  • Experience in a product notification/documentation control/regulatory compliance or a similar role.
  • Knowledge of regulations relevant to cosmetics or food/food supplements in global markets.
  • Excellent English skills, both written and verbal.
  • Ability to speak French.
  • Able to be enthusiastic, a self-starter with good initiative and a proactive approach to work.
  • Ability to work in a very busy environment and to manage change effectively.
  • Must have passion for innovation, new ideas, teamwork and an open mind.
  • Must have a high level of proficiency in MS Office (Microsoft Word, Excel, Teams and PowerPoint), and knowledge of Adobe Acrobat, Data Management Systems.
  • Experience in product registrations.

8. BS in Microbiology with 4 years of Experience

  • Must be collaborative and able to influence change.
  • Must be flexible and strive for continuous improvement.
  • Able to work in a global environment with multiple and diverse cross-functional teams and subject matter experts/corporate partners.
  • Must be cross-culturally competent and customer service-oriented.
  • Must have good Time-Management skills.
  • Able to work independently and proactively search out solutions to challenges by obtaining data from multiple and diverse resources, and support regulatory filings.
  • Able to demonstrate initiative by providing input with respect to continuous improvement opportunities for tools, systems and processes.
  • Able to identify risk, with mitigations and resolutions to be presented to cross-functional teams.
  • Able to construct, support and manage high-visibility project plans in support of assigned projects.
  • Able to prioritise workload and meet established goals and timelines per agreed regulatory strategy and plans.
  • Must track, coordinate and procure required documentation for EU regulatory submissions.
  • Able to identify risk/root cause and provide options for resolution to the regulatory affairs team accordingly with minimal impact on registration timelines.
  • Must have analytical skills to interpret regulatory data in order to be able to verify data accuracy and search out the appropriate information.
  • Able to identify areas for improvement in systems, project plans and processes.
  • Able to make quality decisions sometimes with incomplete information, whilst able to deal with uncertainty/risks and grasp the essence of the issue.

9. BA in Public Health with 6 years of Experience

  • Experience in government, government affairs, public policy, or stakeholder relations, ideally with a focus on e-commerce.
  • Must have an interest in the business and related technology.
  • Excellent communication skills (both oral and written) in English.
  • Working knowledge of any other language to facilitate cross-border discussions and collaborations.
  • Ability to pay attention to detail and accuracy.
  • Strong interpersonal skills and a troubleshooting-oriented mindset that enable working with a multi-cultural group of professionals.
  • Previous experience working for or engaging with industry associations, regulatory agencies, tax authorities, or relevant government agencies.
  • Deep interest and experience in government engagement strategy and implementation.
  • Experience in stakeholder management and planning and ability to collaborate with senior stakeholders across multiple sites/global locations.
  • Strong project management skills to meet deadlines, establish clear priorities quickly and bring projects to completion on time and within budget.
  • Ability to understand the business model, the company strategy and legal/regulatory challenges and ensure KPIs are aligned to this strategy.
  • Excellent problem-solving skills, self-motivated, with strong analytical thinking.
  • Ability to perform under time constraints.

10. BS in Pharmaceutical Sciences with 4 years of Experience

  • Experience in the medical device industry.
  • Relevant experience dealing with government officials.
  • Fluent in spoken and written English and the local language.
  • Must have computer skills, MS Office, and Hangul.
  • Ability to understand the regulatory environment.
  • Ability to understand compliance rules, guidelines, and regulations.
  • Ability to partner with other areas of Philips.
  • Experience in assembling the technical document.
  • Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape.
  • Ability to work in a matrix organization and be agile.
  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment.
  • Must have a positive and enthusiastic personality.

11. BA in Psychology with 3 years of Experience

  • Experience working in the vehicle section of the Managed Services area, either in client service or service operations.
  • Strong working knowledge of vehicle legalization services.
  • Must be proficient in the use of a PC and MS Office Suite.
  • Strong organizational skills.
  • Must have a commitment to providing outstanding client service.
  • Multi-tasking and the ability to refocus upon demand.
  • Ability to work effectively with internal associates and external clients.
  • Good communication skills, verbal and written.
  • Ability to work independently or within a team environment.

12. BA in Environmental Science with 6 years of Experience

  • Knowledge of satellite communications systems (link budgets, general radio theory and basic orbital mechanics), national and international spectrum regulations, policies and spectrum regulatory, registration and coordination processes.
  • Knowledge of non-satellite wireless products, services and technologies.
  • Experience of working in international regulatory fora (ITU, CEPT).
  • Understanding of policy and regulatory issues in the satellite sector, especially with regard to licensing and market access.
  • Strong organization and communication skills.
  • Ability to work with diverse groups and strong teamwork skills.
  • Knowledge of programming languages and/or interference analysis software.
  • Proficient in a second/third language.
Relevant Information
Director of Regulatory Affairs Skills, Experience, and Job Requirements