Regulatory Project Manager

Description

MAIN PURPOSE OF ROLE

• As an individual contributor, the function of a REGULATORY PROJECT MANAGER 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 post marketing 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.

Education

• Bachelors Degree (± 16 years)
• In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical field is preferred.
• an equivalent combination of education and work experience

Experience

• Minimum 2 years 
• 2-3 years experience in a regulated industry (e.g., medical products, pharmaceutical, nutrition).
• Regulatory Affairs 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.)