Job Description

JOB DESCRIPTION:Main ResponsibilitiesResponsible 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 organizations 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 corporations 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 includeCountry specific regulatory support.AccountabilityScope 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:xc2xb7Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporationxc2xb7Provides leadership by communicating and providing guidance towards achieving department, division and/or corporate objectivesxc2xb7Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational unitsxc2xb7May lead a project team or initiative within department or cross-functions/divisionsxc2xb7Provides technical leadership to business unitsxc2xb7Exercises judgment independentlyxc2xb7Leads assigned departments by developing, communicating, and building consensus for goals and programs that support division, business unit and company objectivesxc2xb7May participate / lead external industry working groups to influence advocacy in alignment with business strategiesPlanning/Organization:xc2xb7Creates mid- to long-range plans to carry out objectives established by top managementxc2xb7Develops and calculates a budget for one or more departments to meet organizational goalsxc2xb7Forecasts future departmental or group needs including human and material resources and capital expendituresxc2xb7Determines and establishes organizational structure and supervisory relationships subject to top management approvalDecision Making/Impact:xc2xb7Assignments are expressed in the form of objectivesxc2xb7Work is performed without appreciable directionxc2xb7Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.xc2xb7Consequences 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 activityQualificationsBachelor's degree (or equivalent); Bachelor's 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 precedentsRegulatory agency structure, processes and key personnelPrinciples and requirements of applicable product lawsSubmission/registration types and requirementsGxPs (GCPs, GLPs, GMPs)Principles and requirements of promotion, advertising and labelingInternational treaties and regional, national, local and territorial trade requirements, agreements and considerationsDomestic and international regulatory guidelines, policies and regulationsEthical 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 unitMonitor company-wide indicators such as market share and profitabilityDevelop least cost, least time means to provide optimal regulatory support for new productsMonitor external environment in area of technical or professional responsibilityDirect and manage the preparation of technical strategic regulatory documentation for agency submissionAbility to:Communicate effectively verbally and in writingCommunicate with diverse audiences and personnelWork with cross-functional teamsWork with people from various disciplines and culturesWrite and edit technical documentsAbility to prepare and present written and oral reports and other presentations to internal and external audiences, including senior management and global regulatory agenciesNegotiate internally and externally with regulatory agencies and participate in political lobbyingPlan and conduct meetingsDemonstrate effective use of negotiation skills to resolve regulatory issues in cross-functional teams to ensure completion of project tasksEffectively negotiate regulatory agreements with global regulatory agenciesNegotiate regulatory and scientific issues with managementAdjust presentation style and content to suit the audienceCognitive Skills or Ability to:Pay strong attention to detailManage projectsCreate project plans and timelinesMust be able to juggle multiple and competing prioritiesThink analytically with good problem solving skillsOrganize and track complex informationExercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining resultsHas broad knowledge of various technical alternatives and their potential impact on the businessExercise good and ethical judgment within policy and regulationsPlan and implement most appropriate strategy to obtain product licensure in least amount of time worldwideUse in-depth knowledge of business functions and cross group dependencies/ relationshipsDefine regulatory strategyAble to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issuesPerform risk assessment or analysisCounsel management on regulatory policies so as to maximize income, minimize competition, and minimize risk to businessDevelop and/or identifies new work processes that will have broad applicability throughout the companyThe base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: AQR Abbott Quality and RegulatoryLOCATION: India
New Delhi : New Friends ColonyADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 25 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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