About the job
Core Job Responsibilities Primary Function/Primary Goals/Objectives:
- Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation.
- Develop and supervise regulatory professionals.
- Have department level influence and be generally recognised as an expert resource both within Abbott and externally.
- May comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.
- Monitor emerging regulatory issues and identify solutions.
- Ensure that data are identified, obtained, and effectively presented for the registration of products worldwide.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Accountable for compliance with applicable Corporate and Divisional Policies and procedures and evaluation of regulatory risks of these documents.
- Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
- Identify need for new regulatory policies, processes and SOPs and approve them; evaluate regulatory risks of corporate policies.
- Provide strategic guidance for product development and planning throughout the product lifecycle.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions.
- Conduct regulatory due diligence for potential and new acquisitions and advise management.
- Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
- Develop regulatory strategies and update based upon regulatory changes.
- Interpret and apply regulatory requirements.
- Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.).
- Recruit, develop and manage regulatory professionals.
- Ensure regulatory data is maintained in electronic systems.
- Depending on specific role, the India Director Regulatory Affairs may be involved in various regulatory activities (oversee activities for regulatory submissions; negotiate with regulatory authorities; oversee processes involved with maintaining annual licenses, registrations; review and approve labeling and advertising and promotional items; ensure external communications meet regulations, etc.).
Supervisory/Management Responsibilities (Influence/Impact/Leadership)
- May manage group or small department, providing direction and guidance to exempt and non-exempt personnel who exercise some latitude and independence in their assignments, including evaluating performance and assisting in career development planning.
- Develop, communicate, and build consensus for operating goals that are in alignment with the division.
- Provide leadership by communicating and providing guidance towards achieving department objectives.
- Interface with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.
- Develop and/or identify new work processes and the improved utilization of resources within groups; investigate and solve problems that impact work processes and personnel across departments.
- Monitor costs of projects and resources within a department.
- Perform work without appreciable direction.
- Execute and manage technical and scientific regulatory activities.
- Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
- Effectively communicate, prepare, and negotiate internally and externally with key stakeholders, various regulatory agencies, trade associations, etc.
- Create immediate to long-range plans to carry out objectives established by top management.
- Develop and calculate a budget for a department or group to meet organizational goals; Forecast future departmental needs including human and material resources and capital expenditures.
- Recommend or modify the structure of organizational units or a centralized functional activity subject to senior management approval.
Minimum Qualifications Minimum Education
Bachelor’s degree (or equivalent) is required. M.S. in a technical area or M.B.A. is preferred.
Education Level Major/Field of Study
Graduate/Post-graduate Preferred area of focus in science (nutrition, dietetics, food technology, biology, chemistry, microbiology, pharmacy for example).
MINIMUM WORK EXPERIENCE
15 + years
- 15+ years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.
- 15+ years of experience in a regulated industry (e.g., nutritional’s, medical products).
Regulatory Knowledge Of (as Applicable)
- Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.
- GxPs (GMPs, GLPs, GCPs).
- Principles and requirements of promotion, advertising and labeling.
Communication Skills And Ability To
- Communicate effectively verbally and in writing.
- Communicate with diverse audiences and personnel.
- Work with and negotiate with people from various disciplines, organizations, and cultures.
- Follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy.
- Prepare and present written and oral reports to internal and external audiences, including senior management and regulatory agencies.
- Negotiate internally and externally with regulatory agencies.
- Evaluate various technical alternatives and perform risk assessment and analysis.
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