Manager, Regulatory Operations & Quality

JOB DESCRIPTION:

This is a unique Manager role in Regulatory Operations where you will be positioned to manage the relationships with external and internal stakeholders, provide regulatory strategies, and product roadmap planning, and evaluate regulatory impact assessments. You will work to identify creative pathways in different markets and deliver on submissions and negotiate with regulatory bodies.

This Position is within the Regulatory Operations organization; supporting Emerging Regulatory Issues; pan-franchise requests; EU MDR DoC translation and approval process; Change Management, etc.

RESPONSIBILITIES:

Strategic Planning:

• Develop new regulatory policies, processes, and SOPs and train key personnel on them
• Evaluate regulatory risks of division policies, processes, procedures
• Provide regulatory input to product lifecycle planning
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes
• Assist in regulatory due diligence for potential and new acquisitions
• Utilize technical regulatory skills to propose strategies on complex issues
• Determine submission and approval requirements
• Identify emerging issues
• Monitor trade association positions for impact on company products
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of   regulatory and related teams
• Recruit, develop, and manage regulatory professionals

Premarket:

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing
• · Evaluate the risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile, prepare, review, and submit a regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies and update internal stakeholders
• Monitor applications under regulatory review
• Communicate application progress to internal stakeholders
• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Manage and execute preapproval compliance activities

Post-market:

• Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information
• Ensure compliance with product post-marketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance
• Ensure external communications meet regulations
• Develop, implement, and manage appropriate SOPs and systems to track and manage product-associated events
• Actively contribute to the development and functioning of the crisis/issue management program
• Analyze product-associated problems and develop proposals for solutions
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
• Report adverse events to regulatory agencies and internal stakeholders
• Provide regulatory input for product recalls and recall communications

SCOPE:

Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining the technical objectives of assignments. Completed work is reviewed from a relatively long-term perspective for desired results. The individual is recognized as a discipline expert and resource in regulatory affairs.

Influence/Leadership:

• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
• Provides leadership by communicating and providing guidance towards achieving department objectives.
• Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• May lead a cross-functional or cross-divisional project team.
• Provides technical leadership to business units.
• Acts as a mentor to less-experienced staff.

Planning/Organization:

• Creates immediate to long-range plans to carry out objectives established by top management.
• Develops and calculates a budget for a department or group to meet organizational goals.
• Forecasts future needs including human and material resources and capital expenditures.
• Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.

EDUCATION AND EXPERIENCE:

Required Qualifications:

• Bachelor’s degree (or equivalent); Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• Minimum of 5 years of experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Note: Higher education may compensate for years of experience.
• People management experience required.

Preferred Qualifications:

• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• 2-5 years of experience in Regulatory Affairs preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.

• Regulatory Knowledge of (as applicable)
• 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 a promotion, advertising, and labeling
• International treaties and regional, national, local, and territorial trade requirements, agreements, and considerations
• Domestic and international regulatory guidelines, policies, and regulations
• Ethical guidelines of the regulatory profession, clinical research, and regulatory process
• Lead functional groups in the development of relevant data to complete a regulatory submission