Director, Regulatory Affairs

Main Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: Strategic Planning:

• Identify need for new regulatory policies, processes and SOPs and approve them.
• Develop and advance the organization s policy and procedures for regulatory affairs and compliance to establish a compliant culture.
• Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Develop global regulatory strategies and update based upon regulatory changes.
• Anticipate emerging issues and develop solutions to them.
• Develop solutions to address issues with other members of management and stakeholders.
• Develop corporate positions on regulatory risk-benefit.
• Create and develop product positioning strategies based upon regulatory requirements.
• Integrate regulatory considerations into the corporation s global product entry and exit strategy.
• Provide guidance for resource and development planning.
• Participate in applicable trade association/industry working groups to influence policy/rule making in alignment with business strategies Pre-market.
• Communicate application progress to internal stakeholders.
• Negotiate 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.
• Ensure pre-approval compliance activities are completed.
• Formulate company procedures to respond to regulatory authority queries postmarket.
• Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
• Ensure a system is in place to manage access to information requests.
• Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
• Identify and present option for risk mitigation to decision makers.
• Ensure adverse events are reported to regulatory agencies and internal stakeholders.
• Manage 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.

Job specific responsibilities may include

• Country specific regulatory support.

Accountability Scope is division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies. Must assure that all deadlines are met and provide effective leadership without direct authority. Individual is recognized as a key opinion leader and resource in regulatory affairs. Influence/Leadership: Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectives Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units May lead a project team or initiative within department or cross-functions/divisions Provides technical leadership to business units Exercises judgment independently Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectives May participate / lead external industry working groups to influence advocacy in alignment with business strategies Planning/Organization: Creates mid- to long-range plans to carry out objectives established by top management Develops and calculates a budget for one or more departments to meet organizational goals Forecasts future departmental or group needs including human and material resources and capital expenditures Determines and establishes organizational structure and supervisory relationships subject to top management approval Decision Making/Impact: Assignments are expressed in the form of objectives Work is performed without appreciable direction Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Consequences of erroneous decisions or recommendations would normally include delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity Qualifications Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 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.) 12+ years experience in a regulated industry (e.g., medical products, nutritionals). 12+ 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. Background / Skills / Knowledge 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 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.

Technical/Business Knowledge of:

• Monitor costs of projects and of human and material resources within a department or unit
• Monitor company-wide indicators such as market share and profitability
• Develop least cost, least time means to provide optimal regulatory support for new products
• Monitor external environment in area of technical or professional responsibility
• Direct and manage the preparation of technical strategic regulatory documentation for agency submission

Ability to:

• Communicate effectively verbally and in writing
• Communicate with diverse audiences and personnel
• Work with cross-functional teams
• Work with people from various disciplines and cultures
• Write and edit technical documents
• Ability to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agencies
• Negotiate internally and externally with regulatory agencies and participate in political lobbying
• Plan and conduct meetings
• Demonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasks
• Effectively negotiate regulatory agreements with global regulatory agencies
• Negotiate regulatory and scientific issues with management
• Adjust presentation style and content to suit the audience

Cognitive Skills or Ability to:

• Pay strong attention to detail
• Manage projects
• Create project plans and timelines
• Must be able to juggle multiple and competing priorities
• Think analytically with good problem solving skills
• 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
• Plan and implement most appropriate strategy to obtain product licensure in least amount of time worldwide
• Use in-depth knowledge of business functions and cross group dependencies/ relationships
• Define regulatory strategy
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues
• Perform risk assessment or analysis
• Counsel management on regulatory policies so as to maximize income, minimize competition, and minimize risk to business
• Develop and/or identifies new work processes that will have broad applicability throughout the company

JOB FAMILY: Regulatory Operations DIVISION: AQR Abbott Quality and Regulatory LOCATION: India > New Delhi : New Friends Colony TRAVEL: Yes, 25 % of the Time t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)