PRIMARY JOB FUNCTION:
As an individual contributor, the function of a Senior 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 play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Assist in SOP development and review
- Provide regulatory input to product lifecycle planning
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
- Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
- Determine trade issues to anticipate regulatory obstacles
- Determine and communicate submission and approval requirements
- Participate in risk-benefit analysis for regulatory compliance
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing
- Compile, prepare, review and submit regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies
- Monitor applications under regulatory review
- Monitor and submit applicable reports 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
Job specific responsibilities may include (choose applicable areas and expand as appropriate);
- Maintain annual licenses, registrations, listings and patent information
- Assist compliance with product postmarketing approval requirements
- Review and approve advertising and promotional items to ensure regulatory compliance
- 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
- Analyze the input of cumulative product changes to current product submissions
- 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
POSITION ACCOUNTABILITY / SCOPE:
- Medical writing
- Advertising and promotion
- Controlled substances (e.g. DEA)
- Restricted substances (e.g. REACH)
- Compendial / standards
- Import / export
- Country specific regulatory support
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 technical objectives of assignments. Work is reviewed upon completion for adequacy in meeting objectives. Individual is recognized as an expert in work group.
- Understands business environment and relates extensive knowledge of internal and external activities to trends.
- Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
- Participates in the development of others by facilitating training and providing feedback and guidance.
- May lead a cross-functional project team.
- Provides technical leadership to business units.
- Acts as a mentor to less-experienced staff.
- Exercises judgment independently.
- Plans and organizes project assignments of substantial variety and complexity.
- Initiates or maintains schedule for projects and project milestones.
- Establishes priorities of individual or project assignments.
- Selects methods and techniques to lead a project to completion.
- Erroneous decisions or recommendations would typically result in failure to achieve organizational objective.
Regulatory Knowledge of (as applicable):
Communication Skills or Ability to:
- 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
- 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
Cognitive Skills or Ability to:
- 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
- Negotiate internally and externally with regulatory agencies
- Pay strong attention to detail
- Manage projects
- Create project plans and timelines
- Think analytically
- Organize and track complex information
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Has broad knowledge of various technical alternatives and their potential impact on the business
- Exercise good and ethical judgment within policy and regulations
- Use in-depth knowledge of business functions and cross group dependencies/ relationships
- Define regulatory strategy with supervision
- Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 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.
Will consider hiring at a lower level depending on experience and education.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Yes, 20 % of the Time
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