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Regulatory Affairs Associate
100 Abbott Park Road Abbott Park, IL 60064 US
Job Description
*Depending on experience
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
MAIN RESPONSIBILITIES
• Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
• Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
• Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Assist in preparation and review of regulatory submission to authorities.
• Maintain annual licenses, registrations, listings and patent information.
• Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional items.
• Assess external communications relative to regulations. Review regulatory aspects of contracts.
• Assist with label development and review for compliance before release.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.
• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Participates in determining goals and objectives for projects.
• Influences middle management on technical or business solutions.
• May interact with vendors.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
Minimum 2 years This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.
Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
Work with cross-functional teams. Work with people from various disciplines and cultures.
Write and edit technical documents.
Negotiate internally.
Pay strong attention to detail.
Manage projects. Create project plans and timelines.
Think analytically and critically.
Organize and track complex information.
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Has a sound knowledge of a variety of alternatives and their impact on the business.
Apply business and regulatory ethical standards.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
BS Required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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