Regulatory Affairs Specialist Goals and Objectives Examples
Obtain and maintain knowledge of regulatory laws, guidelines, and industry standards.
Ensure compliance with all regulatory requirements in product development and submission processes.
Collaborate with cross-functional teams to create and submit regulatory filings.
Prepare and submit regulatory documentation to health authorities on time and within budget.
Coordinate the technical review process for regulatory submissions.
Provide regulatory guidance and support to internal teams.
Manage the preparation, submission, and maintenance of global regulatory dossiers.
Monitor regulatory trends and changes in regulations, communicating them to relevant stakeholders.
Serve as a subject matter expert in regulatory affairs for internal and external audiences.
Develop and implement strategies for obtaining timely regulatory approvals for new products.
Facilitate communication between regulatory agencies and the company.
Maintain and update product labeling to ensure regulatory compliance.
Conduct regulatory risk assessments for new products or potential acquisitions.
Participate in post-market surveillance activities, including adverse event reporting and follow-up.
Review promotional materials to ensure compliance with regulations and guidelines.
Manage the interaction between the company and regulatory agencies during audits or inspections.
Provide training related to regulatory requirements to internal personnel.
Implement systems to ensure that safety information is collected, analyzed, and communicated appropriately.
Maintain up-to-date knowledge regarding new product development, manufacturing, testing, and distribution.
Evaluate proposed changes to products or manufacturing processes for potential regulatory impact.
Ensure that all documentation associated with the regulatory submissions is properly stored and maintained.
Develop standard operating procedures (SOPs) related to regulatory affairs activities.
Prepare reports summarizing regulatory activities and outcomes for management review.
Manage timelines for regulatory submissions and respond to inquiries from regulatory agencies in a timely manner.
Develop quality management plans for regulatory compliance purposes.
Work collaboratively with research and development teams to ensure regulatory compliance throughout product development.
Review and evaluate proposed clinical study protocols for potential regulatory implications.
Maintain records related to regulatory submissions, including correspondence with regulatory agencies.
Conduct internal audits to ensure compliance with regulatory requirements.
Develop and maintain relationships with regulatory authorities and industry associations.
Ensure compliance with good manufacturing practices (GMPs), including quality system regulation (QSR).
Facilitate the development of contingency plans in the event of a regulatory emergency.
Manage the preparation and submission of biologic license applications (BLAs) and new drug applications (NDAs).
Assist with the management of clinical trial data and documentation.
Ensure that preclinical and clinical data is accurately collected, analyzed, and reported for regulatory approval purposes.
Assist with the preparation of regulatory responses to questions or deficiencies identified by health authorities.
Work collaboratively with legal counsel on regulatory issues and matters related to intellectual property.
Provide input into product development activities related to regulatory requirements.
Manage the preparation and submission of drug master files (DMFs).
Participate in due diligence activities related to potential mergers, acquisitions, or partnerships.
Evaluate labeling requirements for drug products in accordance with regulations and guidance documents.
Develop and manage the maintenance of technical files and design dossiers as per EU Medical Device Regulation (MDR)/In-vitro Diagnostics Regulation (IVDR).
Maintain a current knowledge of global medical device regulations, guidelines, and industry standards applicable to our products and markets.
Provide support to R&D project teams during product development activities, including design controls, risk management, post-market surveillance activities, etc.
Manage the preparation and submission of Technical Files and Design Dossiers for CE marking.
Ensure compliance with labeling requirements for medical devices in accordance with regulations and guidance documents.
Assist in the development of global regulatory strategies for medical devices.
Participate in risk management activities related to Medical Devices.
Develop and maintain policies and procedures related to regulatory affairs activities.
Interact with international regulatory agencies regarding product registrations.
Coordinate the preparation of International Technical Files and Design Dossiers for medical devices.
Provide guidance on regulatory requirements to other departments within the company.
Manage the preparation and submission of 510(k)s for US FDA clearance.
Keep abreast of changes in US FDA regulations, guidelines, and industry standards applicable to our products and markets.
Identify and evaluate regulatory implications of changes in product design, labeling, or manufacturing processes.
Ensure that all required documentation is included in regulatory submissions.
Work closely with project teams to identify potential regulatory roadblocks to product development timelines.
Prepare responses to regulatory agency questions or deficiencies identified during the review process.
Assist in the preparation and submission of Investigational Device Exemptions (IDEs).
Evaluate proposed clinical protocols for potential regulatory implications.
Interact with Clinical Affairs and Biostatistics teams to ensure that data submitted in regulatory filings is accurate and complete.
Manage the preparation and submission of drug establishment registration and listing submissions.
Ensure that all adverse event reports are timely submitted per regulations.
Provide assistance with the maintenance of quality systems per applicable regulations, including global product registrations.
Assist with post-market surveillance activities, such as trend analysis or annual reporting requirements.
Collaborate with legal counsel on regulatory issues related to intellectual property.
Develop regulatory strategies for combination products.
Provide input into product development activities related to regulatory requirements for combination products.
Manage the preparation and submission of Combination Product Applications (CPAs).
Keep abreast of regulatory developments related to combination products.
Provide regulatory guidance to other departments within the company regarding combination products.
Manage the preparation and submission of Pre-Market Approval (PMA) applications for medical devices.
Ensure compliance with US FDA regulations, guidelines, and industry standards applicable to our products and markets.
Evaluate proposed changes to medical device design, labeling, or manufacturing processes for potential regulatory impact.
Review promotional materials to ensure compliance with US FDA regulations and guidelines.
Maintain a current knowledge of changes in US FDA regulations and guidelines applicable to our products and markets.
Collaborate with project teams on regulatory strategies for new product development.
Manage the preparation and submission of 510(k) Supplements.
Prepare responses to US FDA deficiency letters related to submissions.
Develop strategies for responding to US FDA warning letters.