Director Regulatory Affairs

1 month ago

Mumbai, India Abbott Laboratories Full time
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 recognized 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. 

Major Responsibilities: 

  • 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.

   

Accountability/Scope: 

  • 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

Experience

Experience Details

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., nutritionalâs, 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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