Associate, Regulatory Affairs Job Description
Associate, regulatory affairs
provides labeling regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
Associate, Regulatory Affairs Duties & Responsibilities
To write an effective associate, regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included associate, regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Advise stakeholders of submission completion
Find information and potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward
Assist in the preparation of regulatory documents
Compile applications and prepare for sign-off, assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor's requirements and guidance
Assist Manager/Director in review of labelling for marketed products and new products as assigned
Coordinate document submission in accordance with supervisor's requirements and guidance
Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable
Use of template correspondence as appropriate, ensuring that all new information is correct
Prepare and review drafts of routine correspondence
Perform any other duties as assigned by the hiring manager
Associate, Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate, Regulatory Affairs
List any licenses or certifications required by the position: RAC, TSE/BSE, RS, RAPS, HAZMAT, PMP, EEO, PPE, CE, UL
Education for Associate, Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the associate, regulatory affairs 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 Associate, Regulatory Affairs
Desired skills for associate, regulatory affairs include:
Industry practices
Product and processes
Techniques and standards
Drug development
Principles and concepts of Labeling
Regulations
Applicable portions of agency regulations and guidance documents
Docubridge
Drug development process
ECTD/CTD/NEES/Paper types of submission
Desired experience for associate, regulatory affairs includes:
Follow up with purchase team for DMFs and compliance to DMF review comments
Prepare and update the road map for each assigned product with committed timeliness by each department
Track the committed timeliness and follow up with the internal departments proactively for required documents
Organize and maintain submission components associated with a regulatory submission electronically
Screen the ANDAs against ANDA checklist to avoid screening queries
Gain more knowledge in the use of e-CTD structures for submissions
Associate, Regulatory Affairs Examples
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Associate, Regulatory Affairs Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of associate, regulatory affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate, regulatory affairs
- Maintain GDUFA Self-Identification status and update annually
- The implementation of regulatory strategies
- Prepare review and approve CCDS’s and SOP’s
- Act as EMEA product owner for products of the portfolio
- Serves as back up to the RA Coordinator for the filing of all MLS’s and labeling samples the updating of required revision lists needed for the Elizabeth plant
- Support continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met
- In collaboration with Marketing, Medical Affairs and other business partners review and approve labeling and promotional material for regulatory compliance
- Participate on project teams to provide regulatory input as assigned
- Contributing to the key of Water products success globally
- Strong knowledge of appropriate software (e.g., Windows File Management, Adobe InDesign, Microsoft Word, Excel, PowerPoint)
Qualifications for associate, regulatory affairs
- Bachelor of Life Science, Masters is desirable but not essential
- Deep and broad knowledge of regulatory affairs
- Must have the ability to work independently in a team environment
- Individual must have proficiency with XML, database, and word processing applications Adobe Professional
- At least 2 years of Regulatory Affairs experience in the Pharmaceutical Industry
- Knowledge of the Canadian Regulatory Framework for pharmaceutical products
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Associate, Regulatory Affairs Job Description
Job Description Example
Our growing company is looking for an associate, regulatory affairs. 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 associate, regulatory affairs
- Remains current on developments in field(s) of expertise, regulatory requirements, industry trends and trains staff regarding changing regulations that affect regulatory submissions
- Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment
- Ability to take initiative to identify challenges and solve problems in an efficient, positive manner
- May contribute to discussions on implementation of business strategy on a regional basis and will set and implement site-specific objectives, as appropriate
- May have financial responsibility and accountability for Regulatory Affairs sites
- May act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation
- Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues
- Actively contribute to high performing teams, including looking for ways to improve performance
- Support project development teams and communicate regulatory progress, decisions, strategies, , with guidance
- Clearly and effectively communicate team/project progress/status, decisions, timelines
Qualifications for associate, regulatory affairs
- Bachelor’s Degree in a related, Communications or Scientific Discipline
- Clear understanding of content and organization of regulatory submissions in eCTD format, ICH and FDA guidances
- Minimum of three years in a Regulatory Affairs pharmaceutical environment
- Bachelor's degree in scientific or engineering area
- 1-3 years of US and EU medical device PRE-market regulatory affairs experience
- RAC certification desired
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Associate, Regulatory Affairs Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of associate, regulatory affairs. 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 associate, regulatory affairs
- Responsible for ensuring timely filing of TMF documentation
- Manage the regulatory CMC aspects of projects/products, including documentation submitted to regulatory agencies and regulatory agency interactions
- Develops, monitors, and reports to senior management key performance indicators
- Leads cross-functional or cross-business teams to address process improvements, major regulatory changes or initiatives (e.g., compliance with new registration requirements, or professional development with minimum supervision)
- Support in the migration to the new global distribution control system and collaborate with the global team and other functions to provide tracking and updated regulatory information
- Compile, organize, file, retrieve, research and maintain document, submissions, logs and records
- Consolidate and harmonize regulatory information collection
- Manage a cross functional team in the gathering of data and information for inclusion in ANDA applications
- Review all ANDA documentation for discrepancies, errors and mistakes prior to submission of the ANDA
- Provide corrections and comments to the contributing departments and assure accurate and complete documentation for inclusion in ANDA applications
Qualifications for associate, regulatory affairs
- Ability to communicate scientific information
- Minimum of a Bachelor’s Degree in a life science
- Minimum of 5 years in the pharmaceutical industry including 3-4 years in regulatory
- Generic pharma regulatory experience (solid dose preferred)
- Extensive knowledge and understanding of complex medical and scientific subject matter evolving FDA policy and guidance related to advertising and promotion topics
- Direct interaction/negotiation with regulatory authorities
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Associate, Regulatory Affairs Job Description
Job Description Example
Our company is looking to fill the role of associate, regulatory affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate, regulatory affairs
- Review labeling and promotional material, as assigned, to ensure compliance of all facets of company business to Health Canada regulations and guidelines, Innovative Medicines Canada (formerly Rx&D) and PABB guidelines
- Leading and facilitating large and small-scale business process mapping sessions while working with process owners and functional SMEs to ensure processes meet business and compliance requirements
- Gather information and prepare IND and NDA annual reports
- Think of solutions to overcome problems in making submission goals
- Assist with all activity relating to the compilation, submission and maintenance of registration application dossiers to South Africa and Southern African Regulatory Authorities, in accordance with established formats
- Responsible for leading and executing the filing and approval of Hematology / Oncology CTAs
- Provide input into Canadian regulatory development & submission strategies, timelines & life cycle management, as assigned
- Provide advice on the regulatory environment & the requirements that must be met to obtain approval of a product for the desired uses in Canada, as assigned
- Interface with global on Canadian regulatory strategy & implementation plans, as assigned
- Coordinate specific project related interactions with Health Canada
Qualifications for associate, regulatory affairs
- BS Life Sciences
- Prior experience preparing IND/NDA submissions is a plus
- Proven track record of relevant regulatory environment (min
- Quality Assurance issues knowledge
- Strong attention to detail and quality in all reporting materials
- Ability to communicate effectively to all levels of organization and customers (including regulators)
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Associate, Regulatory Affairs Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of associate, regulatory affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate, regulatory affairs
- Identify, develop, implement and document process improvements to drive efficiency within the organization with approval of Regulatory management
- Manage local statutory reporting requirements, as required
- OTo request documentation from internal and external bodies to support registration applications
- Assist in SOP development
- Organize materials from preclinical and clinical studies for review and assist in review process
- Compile and organize materials for pre-submission reports
- Coordinate and assist in the preparation of submission/registration packages
- Coordinate registration requests and track completion
- Oversee quality control of regulatory documents and submissions
- Organize meetings with regulatory agency staff
Qualifications for associate, regulatory affairs
- Excellent written and verbal communication skills including ability to communicate across culture
- Familiar with Design control documents
- Minimum of 7 years of direct applicable regulatory experience in medical devices, IVD experience a plus
- Bachelor's Degree in a technical related field of study is required
- 8 years of relevant regulatory experience
- Experience interfacing effectively with regulatory agencies