A Regulatory Affairs Consultant is hired to assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. Duties vary based on the requirements of the organization, however, a professional Regulatory Affairs Consultant Resume mentions the following core duties – handling document preparation, information management, file maintenance, and coordination of tasks across multiple departments, explaining regulations, policies and procedures; ensuring compliance with regulations, evaluating applicable laws and regulations to determine the impact on company activities, providing technical review of data or reports, coordinating regulatory documentation activities, and interpreting relevant regulatory guidelines.
Entry-level professionals have a bachelor’s degree, with majors in subjects such as biochemistry, biological sciences, pharmacy, toxicology, medicine, and engineering. However, for advancing in the career, a master’s degree in clinical research studies, engineering, or a terminal degree may be required.
Objective : Hands-on Project Manager with over 5 years' project management experience with Fortune 500 pharmaceutical companies and an extensive background in regulatory processes including remediation protocols, quality assurance and compliance. Strengths include Data Analysis, determining Trends & Systemic issues, Managing Change Controls, Regulatory Compliance, Labeling and Submissions.
Skills : Qualified Process Hazards Analysis.
Description :
Assessed global regulatory risk to currently marketed products and recommends remediation, as necessary, to bring products into compliance globally in a complex environment.
Managed the preparation and review of registration packages to ensure effective data presentation and quality.
Managed, edit and developed protocols per FDA guideline to meet required specifications.
Strong knowledged in FDA and ICH guidelines, and ANDA /NDA requirements, ensured that the methodology used and experimentation performed met validation and verification requirements.
Led and trained junior regulatory affairs specialist in identifying gaps.
Provided support and mentored to junior specialist in the redlining process according to SOPs and Corporate policies.
Maintained scheduled timeline of gap remediation for final approval Responsible for executing gap remediation activity in accordance with project milestones.
Experience
2-5 Years
Level
Executive
Education
Bachelor's In Health Administration
Regulatory Affairs Consultant Resume
Objective : As a Regulatory Affairs Consultant, responsible for Working closely and providing advice with executive management, engineering, operations, legal, information technology, human resources, customer service, and financial staff within the Company to include counterparts across all Emera affiliate companies and internal auditors.
Skills : Consultation SKills, Maintenance Skills.
Description :
Analyzed and provided interpretation of newly enacted laws and guidelines that include, as appropriate, relevant legislative history, comparisons to existing or proposed legislation in other jurisdictions and detailed descriptions of the operational requirements and affected departments.
Supported and coordinated with business partners with articulating responses to proposed regulatory changes to drive achievement of business goals and clarity of regulators expectations.
Consulted and coordinated with new business / sales / product development to determine applicable regulatory requirements pertaining to any products being offered in the marketplace.
Maintained awareness of current and emerging trends/changes in the regulatory environment.
Analyzed Medicaid state contracts for MCOs and all associated policies that align with adherence to that contract.
Knowledged of health care compliance programs and processes.
Researched, interpreted, and understood state and federal laws and regulations.
Experience
2-5 Years
Level
Executive
Education
Bachelor's In Health Administration
Regulatory Affairs Consultant Resume
Objective : Regulatory Affairs Consultant Professional with fifteen years of track record working for Food and Beverages industries; has extensive experience interacting with the Food and Drug Administration (FDA), the United State Department of Agriculture (USDA), and other U.S., Canadian and Mexico regulatory agencies on both technical and policy levels.
Supported the achievement of Interbake's overall business goals by assessing and assuring the safety and regulatory compliance of ingredients, flavors, packaging, promotional items and new technologies currently used or being considered by the Company.
Recommended and implemented strategies for the safety evaluation and regulatory approval of new ingredients and/or technologies, works with external partners to ensure testing is adequate, and conducts assessments to determine safe use levels of both new and existing flavors and ingredients.
Proactively identified any potential safety and regulatory issues that may impact the business and took appropriate actions to forestall or minimize such problems.
Ensured that products are within compliance with local, state, federal and International food regulations, including the CFIA, USDA & FDA labeling laws.
Tracked and evaluated governmental and state regulations and their impact relative to the current and future business.
Assisted in resolving regulatory issues pertaining to food safety such as allergen, labeling, residue, recall, etc Lead the development and implementations and direction for the Interbake Group of ensuring that the company's packaging meet ingredient, nutritional, GFSI, food safety, and labeling regulation requirements for US, Canada and Mexico.
Provided food labeling expertise and collaborates with government, company divisions, certifications bodies and bakeries on regulatory compliance affairs related regarding ingredients and final products.
Experience
2-5 Years
Level
Executive
Education
Diploma
Regulatory Affairs Consultant Resume
Headline : Regulatory Affairs Consultant, with over 6 year's recruitment experience working on full desk and RPO recruitment in the UK and US. Dedicated to developing the best service to clients, employees, and candidates. Consistently a top biller in current global recruitment company. Professional nature, loves working in a fast paced environment, with a true passion for placing the perfect candidate in the right role.
Skills : Microsoft Office, Matlab, Developing Skills.
Description :
Managed a full 360 recruitment desk specializing within Regulatory Affairs roles within global leading pharmaceutical companies.
Resourced candidates for jobs using the internal database, LinkedIn, and job boards.
Wrote detailed web adverts.
Networked with candidates on LinkedIn and TOPRA events to gain credibility in the industry.
Attended graduate events, pharmaceutical conferences to raise brand awareness, gaining new candidate and client awareness.
Advised product developers in formulating products to meet desired claims (such as organic certification, Allergen, Natural claims; etc) and/or nutritional requirements.
Developed sound regulatory decisions and participate and lead in regulatory strategy meetings for clinical, CMC, and labeling projects Performs.
Experience
5-7 Years
Level
Executive
Education
MS
Regulatory Affairs Consultant Resume
Objective : As a Regulatory Affairs Consultant, responsible for Performing research, and maintaining awareness of licensing and other regulatory agency requirements and changes in city, county, state, and other municipality requirements, Ensuring licensing and agency compliance from school, District, and Company personnel, Receiving incoming compliance-related documents and distributes to appropriate Support Center personnel to ensure timeliness in processing and that deadlines are met.
Skills : Consulting Skills, Documentation Skills.
Description :
Assisted with the remediation efforts utilizing internal letters-to-file which included: Letters-to-File (LTF), Justification for bundling scopes, Letters-of-Compatibility (LOC), and Subordinate-Letters-to-File.
Mastered Files, IDE, Class III -Authored Letters of compatibility based on scientific, electronic components, chemical components, and mechanical engineering of device families.
Assisted in facilitating a workshop with external strategic partners.
Authored key components for the deficiency letter or the 483 Response Letter to the FDA.
Participated in CAPA training program for the company.
Authored key regulatory documentation at Pentax Medical as a Regulatory Affairs Consultant including a 483-response letter to the FDA this included key regulatory submissions resulting in approval for substantially equivalent medical devices for endoscopy.
Developed regulatory strategies and provided continuing regulatory guidance throughout project development up through commercial marketing of projects.
Experience
2-5 Years
Level
Executive
Education
Masters Of Science
Regulatory Affairs Consultant Resume
Headline : Ability to identify, understand, measure, communicate, and mitigate conformance risks related to CMC regulatory processes and systems, such as CMC change management for Commercial and Investigational products, investigations, and commitments. Strong leadership skills with proven results in making authoritative business decisions, executing decisions, and accounting for results Working knowledge of FDA regulations, ICH guidelines, CGMPs, and GCPs.
Skills : Interpersonal Skills, Communication Skills, Reviewing Skills.
Description :
Led management of projects, partner with regulatory affairs (RA) teams to develop applications and interface with clients.
Prepared and submitted compendial/non-traditional product license applications, drug identification number (DIN) applications, and veterinary new drug submissions.
Garnered market authorization of compendial applications, DIN applications, and submit product notifications and amendments earning successful legalization by securing certification of pharmaceutical products for various countries.
Administered and reviewed product labeling for compliance and regulations applying Category IV and Labeling Standards for DIN submissions and also ensure cosmetic labeling standards.
Developed responses to Clarifaxes and Information Requests from Health Canada pertaining to natural health products, therapeutics products, and veterinary drug directions and reviewed product notifications and amendments.
Orchestrated quality assurance for product releases, review laboratory test results and batch records.
Supported internal and external audits as needed.
Experience
5-7 Years
Level
Executive
Education
Bachelors
Regulatory Affairs Consultant Resume
Summary : Regulatory Affairs Consultant is responsible for Reviewing compliance documents, records data organizing compliance information, and partners with other Support Central departments in an effort to improve the overall regulatory compliance throughout our organization, including ad-hoc compliance administrative duties, collecting, processing, reviewing, and analyzing regulatory correspondence.
Reviewed change control documentation and provided regulatory guidance to manufacturing sites and laboratories.
Responsible for tracking and completion of assigned remediation activities.
Responsible for effective cross-functional coordination of remediation activities.
Identified regulatory activity and interact with cross-functional teams to execute action items.
Communicated status of remediation and issues on a timely basis with peers.
Managed all research protocols, including Animal Care and Use Committee (ACUC), Institutional Biosafety Committee (IBC), Internal Review Board (IRB) protocols, and other documents as needed for researchers in the Therapeutics Discovery Division.
Consulted with research staff to design new protocols or protocol amendments, and updated documents accordingly.
Experience
10+ Years
Level
Senior
Education
High School Diploma
Regulatory Affairs Consultant Resume
Objective : As a Regulatory Affairs Consultant, responsible for Coordinating of CTA filings and Marketing Authorization Applications in rest of world countries Strong leadership skills with proven results in making authoritative business decisions, executing decisions, and accounting for results, Working knowledge of FDA regulations, ICH guidelines, and cGMPs, Knowledge of CMC regulatory requirements and document preparation within a common technical document (CTD).
Developed and implemented standard practices and operating procedures to ensure all required protocols remain active and compliant with institutional and governmental directives, as well as accurately reflect the research activities of the team.
Served as liaison to provide information and facilitate modifications of regulatory protocols for collaborators working with the Therapeutics Discovery Division.
Maintained a positive and productive working relationship with the offices that oversee animal research, biohazardous materials, and human subjects research, as well as with collaborators.
Assisted in grant setup by responding to compliance requests related to regulatory protocols.
Submitted and managed Material Transfer Agreements (MTAs), including submitting and managing regulatory protocol submissions to facilitate MTA approval.
Submitted and managed Research Contract Tracking System (RCTs) submissions, including submitting and managing regulatory protocol submissions to facilitate RCTS approval.
Experience
2-5 Years
Level
Executive
Education
MS
Regulatory Affairs Consultant Resume
Objective : Regulatory Affairs Consultant with 3+ years of experience in Supporting the team on internal or external communication related to testing requirements, Monitoring URBNs e-commerce sites to ensure products are compliant, and also Assisting with collection of Conflict Minerals surveys to support URBNs annual SEC filing, Conducting routine Regulatory Compliance audits of our vendor base and product assortment
Skills : Consulting Skills, Project management.
Description :
Attended team meetings to maintain a working knowledge of scientific priorities of the Therapeutics Discovery Division.
Maintained collaborative relationships with leadership and laboratory staff to ensure the advancement of goals.
Maintained knowledge and organized records of activities related to regulatory protocol management.
Refined writing and content to achieve the greatest impact.
Prepared reports and proposals using standard institutional templates that are clearly understood by the audience.
Authored research papers for publication in accordance with procedures.
Prepared project plans, reports, and proposals using universally standard business writing guidelines.
Experience
2-5 Years
Level
Executive
Education
MS
Regulatory Affairs Consultant Resume
Objective : To obtain a Regulatory Affairs Consultant, responsible for Organizing data related to Prop 65 compliance and communicating to the Brand teams, Communicating with URBNs distribution centers to resolve issues related to Regulatory Compliance, Staying abreast of new and updated regulations and apply relevant updates to URBN documents.
Skills : Data Analyst, Organizational Skills.
Description :
Modeled team qualities, i.e. respect, helpfulness and coping.
Supported team decisions once they are made and help to implement.
Actively promoted a spirit of cooperation and teamwork.
Solicited opinions from team members.
Coached others in developing teamwork skills.
Maintained state of the art knowledge in the field.
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