PRIMARY JOB FUNCTION:
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.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
- Assist in SOP development and review
- Provide regulatory input to product lifecycle planning
- 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
- Determine and communicate submission and approval requirements
- Participate in risk-benefit analysis for regulatory compliance
- Monitor applications under regulatory review
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
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
- 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
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, understand regulations and guidance. Individual works under minimal supervision and independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Participates in conflict resolution at the team level.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
- May lead a departmental project team.
- Participates in determining goals and objectives for projects.
- Influences middle management on technical or business solutions.
- May interact with vendors.
- Plans and organizes non-routine tasks w/approval.
- Initiates or maintains work schedule.
- Establishes priorities of work assignments.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
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 Experience / Training Required:
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.
Note: Higher education may compensate for years of experience.
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
- Write and edit technical documents
- Negotiate internally
Significant Work Activities and Conditions
- Strong attention to detail
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
- 2 years ago - save job