Regulatory Affairs Associate Job Description
Regulatory affairs associate
provides expert regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
Regulatory Affairs Associate Duties & Responsibilities
To write an effective regulatory affairs associate job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7, M4 and related guidance, FDA regulations
Ensures site regulatory policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA
Prepare and review ROCs for routine FDA contacts
Maintain current knowledge of regulations and other issues that affect products and industry
Assess the impact to the implementation of required company compliance with all regulations, laws and industry policies
Apply Microsoft Office programs and the company's systems relevant to area of responsibility to deliver against project strategy
Prepare and assist submitting eCTD submissions for generic and new drug development projects and marketed products to ensure timely submissions to the FDA
Assist and/or manage electronic submissions to FDA in eCTD format
Ability to understand and execute government regulations
Complete structured regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers for submission to Health Authorities [DMFs, MAFs, 510(k)’s], customer requests, in compliance with regulations, guidelines and procedures
Regulatory Affairs Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs Associate
List any licenses or certifications required by the position: RAC, TSE/BSE, RS, RAPS, HAZMAT, PMP, EEO, PPE, CE, UL
Education for Regulatory Affairs Associate
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Pharmacy, Engineering, Chemistry, Life Sciences, Biology, Technical, Medical, Education, Pharmacology
Skills for Regulatory Affairs Associate
Desired skills for regulatory affairs associate include:
Regulations
Microsoft Office
English language
Scientific principles
FDA
ICH Guidelines
Regulatory requirements
Drug submissions
FDA PMA guidance documents and CFR regulations
GMP
Desired experience for regulatory affairs associate includes:
Disseminate intelligence in a timely manner, to relevant groups within RA/CMR, NN-US
Fulfill regulatory intelligence research requests in support of therapeutic area projects
Assist manager in gathering the company's comments on draft guidance and proposed rules
Compose letters incorporating the company's position for submission to regulatory authorities and external trade organizations
Assist with compilation of biweekly newsletter and monthly report
Assist with overflow in other areas as needed and handle other duties and/or special projects as assigned by the Manager, Director or Associate VP, Regulatory Affairs
Regulatory Affairs Associate Examples
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Regulatory Affairs Associate Job Description
Job Description Example
Our company is searching for experienced candidates for the position of regulatory affairs associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs associate
- Prepare FDA domestic and international submissions for new products and product changes as required to ensure timely approval for market release
- Maintain registration and listing database for Acclarent for FDA-regulated products
- Ensure regulatory affairs product files are appropriately maintained to support compliance with regulatory requirements
- Attend trade association / Regulatory Agency meetings and represent the company's interests with key government agencies while remaining competitive
- Proactively manage and communicate issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed
- Understand stakeholders timelines and objectives
- Develop and communicate submission strategies to the cross-functional project team, including strategies required for integration of any merger, acquisition, or 3rd party license
- Oversee the preparation, review/approval, and dispatch of the regulatory submission
- Coordinate responses to Regulatory agency questions
- Utilize online resources and programs to navigate key external agency and trade association web sites
Qualifications for regulatory affairs associate
- Author and review multiple and more complex departmental SOP / work practices
- Prepare and assist submitting Drug Listing and SPL/PLR submissions
- Assist in reviewing change control documents, batch records, and other technical documents
- Coordinate and work with Regulatory/R&D colleagues for the preparation regulatory submissions
- Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency
- Organize and maintain Regulatory application records and indices in the Regulatory Operation Center
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Regulatory Affairs Associate Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory affairs associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory affairs associate
- Working knowledge of chemical product regulatory requirements (current local, state, federal and international regulations)
- Advocates least burdensome approaches to product clearance/approval, interpreting and providing regulatory requirements
- Use complicated, FDA specific, computer software to input, publish and validate all data required for the eCTD ANDA
- Review all pertinent documentation and submit Annual reports, as required by the FDA, for all approved ANDAs
- Interpret regulatory requirements and determine strategy to obtain registrations
- Knowledge of USDA regulations while remaining up-to-date on regulation changes
- Ability to troubleshoot layouts and files efficiently and effectively
- Accurate with a strong attention to detail
- Demonstrated ability to balance multiple priorities and meet strict deadlines in a fast-paced environment
- Ability to effectively present information and respond to questions from groups of peers, customers and managers
Qualifications for regulatory affairs associate
- Good communication, organizational and time management skills with the ability to multi task
- Demonstrated competency using actual or like IT systems such as
- Demonstrated ability to generate rapid, positive change within an organisation
- BS/BA degree in an engineering or scientific discipline with 0-2 years of experience in International regulatory affairs/compliance, preferably in Latin America
- Strong regulatory compliance documentation skills
- Experience with at least one of
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Regulatory Affairs Associate Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory affairs associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory affairs associate
- Examine regulations, guidance & competitive landscape in relation to assigned tasks & provide feedback and recommendations to local management and global regulatory affairs as needed
- Oversee planning, preparation, and submission of the CMC sections of marketing and clinical trial applications globally
- Provide regulatory affairs post-market support for company devices assist with new product submissions
- Respond to requests for Regulatory supporting documentation (i.e, CFG’s, ISO certificates)
- Supplier Licensure Database
- Prepare and execute regulatory strategies/plans
- Provide support to new and currently marketed products, as necessary, including reviewing product labelling and preparing product changes notices and associated documentation for changes requiring regulatory approval
- Prepare, submit and review engineering and document change notices, as required
- As required, assist RA/QA teams during inspections by Notified Bodies and Competent Authorities
- Provide support to regulatory meetings with Regulatory Agencies Competent Authorities
Qualifications for regulatory affairs associate
- Serve as the Regulatory Affairs representative on project teams
- Maintain awareness of and communicate changing regulatory agency requirements
- Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 6 years of increasingly responsible regulatory experience in the pharmaceutical industry
- Consideration for candidates with combination device regulatory affairs experience
- 5% - 10% (Projects, Meetings, Training)
- Minimum of a Bachelor’s degree in a science related discipline
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Regulatory Affairs Associate Job Description
Job Description Example
Our company is looking to fill the role of regulatory affairs associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs associate
- Review and approve specific change controls as they relate to regulatory submissions
- Participates on project teams or sub-teams for the planning of activities needed to meet development program objectives
- Skilled in product responsibility/product safety duties
- Provide regulatory guidance to result in comprehensive, cohesive, and compliant submissions
- Maintain, update, and submit USDA required documents as directed by Manager
- Administer department databases required for accurate tracking of registrations and/or commitments
- Work independently, effectively, and flexibly within and across all Elanco RA, R&D, Manufacturing, Quality, and Marketing teams, external collaborators and agencies, to assist in achieving Elanco registration deliverables
- Create an engaging culture with “play to win” mentality
- Identify and utilize methods to deliver individual objectives in a high quality, timely, and cost-effective manner
- Maintains company databases and compliance related IT tools
Qualifications for regulatory affairs associate
- Minimum of 2-5 years of experience working in Regulatory Affairs
- Familiar with the preparation and maintenance of regulatory submissions
- Understanding of eCTD submissions
- BS Engineering or Chemistry, Microbiology, Biology, (Life Science)
- Recent graduates up to 3 years regulatory affairs exp
- Proficient with Microsoft Word and Excel, Adobe Acrobat X or higher
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Regulatory Affairs Associate Job Description
Job Description Example
Our growing company is looking to fill the role of regulatory affairs associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory affairs associate
- May review Promotional Materials for assigned products
- May lead process improvement initiatives within Regulatory Affairs
- You have high learning agility
- You have a competitive mindset and are driven to achieving results through effective implementation of regulatory strategy
- You are a strategic thinker, with proven analytical skills
- You have ability to collaborate effectively across multiple internal and external stakeholders
- You have highly developed verbal and written communication skills
- Compiling (assembling submission content, organization of document legalization/apostille, and creation of any other documents required for submissions) and maintenance of international regulatory submissions and other premarket registrations for Latin America markets to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan
- Document appropriate regulatory strategy for proposed new products or product changes and initiate necessary activities with Regulatory management approval
- Support Regulatory Affairs representatives on assigned project teams by attending team meetings and providing the required plans, procedures and regulatory decisions
Qualifications for regulatory affairs associate
- Minimum 2 years experience in Regulatory or equivalent training and experience in related function such as Clinical or Nonclinical
- Speak the local language
- Comfortable experience with Database entry and management
- General knowledge of “good documentation practise”
- Position requires a Master’s degree (or an equivalent foreign degree) in Regulatory Affairs or a closely related field
- 1 year of experience performing the duties of the position offered or performing both pre- and post-market regulatory activities related to regulatory submissions for medical devices, medical device recalls and/or MDRs