Position Description
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Provide strategic oversight to the regulatory function within the Asian Region on behalf of our client. Work is performed under consultative direction towards corporate regulatory goals and objectives. Schedules and arranges own activities and those of direct report(s).
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Summary of Key?Responsibilities:
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Registration
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Work with in-country Regulatory Head to manage contact with national authorities for any regulatory issues regarding licences.
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Formulate regulatory strategy for submission activities in the Asia Region, ensuring alignment with key stakeholders (commercial, corporate, medical, R&D).
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In conjunction with in-country Regulatory Head, liaise with International Regulatory Affairs regarding the preparation of any submissions relating to our clients products (including clinical trials, NCEs, variations and line extensions).
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Provide oversight, in conjunction with in-country Regulatory Head, regarding submission of PSURs, urgent safety restrictions and safety variations for national products, in liaison with Global Drug Safety & Public Health and International Regulatory Affairs.
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Coordination of distribution of Dear Healthcare Provider Letters.
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Formulate regulatory strategy for Clinical Trial Authorisation applications and subsequent applications (amendments etc), and work with in-country Regulatory Head to ensure submission to agreed timelines.
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Provide regulatory input/support to Asian Region cross-functional initiatives (with commercial and medical groups).
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External Liaison and Strategy in Assigned Territories
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Establishment of good working relationships with national authorities in the Asian Region.
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Establishment of good working relationships with regulatory groups of commercial partners in the Asian Region.
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Provision of strategic regulatory advice regarding national registration requirements to senior management and International Regulatory Affairs for countries of responsibility.
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Communication to International Regulatory Affairs and Drug Safety & Public Health of any new or changed national regulatory legislation/guidance/situation which may affect our client?s regulatory or pharmacovigilance strategy.
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Participation in agreed industry working groups.
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Proactively identify regulatory trends across the Asian Region, and positively influence the regulatory environment to our client?s advantage where possible.
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Commercial Compliance Activities
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Having oversight of the provision of scientific information about our client?s medicinal products in the Asian region for countries where they work with local commercial partners.
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Establishing and maintaining in conjunction with local General Managers, Medical Affairs, Legal and Regulatory Compliance, a programme of training and auditing of the provision of medical information and adherence to legislation,?codes of practice and their internal guidelines concerning promotion and advertising of their medicinal products.
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Provision of guidance and assistance to Marketing during preparation of promotional material.
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Review and approval of promotional material in accordance with our client?s internal promotional guidelines, national legislation and Codes of Practice.
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Ensure provision of updated approved product labelling to relevant personnel, for all products.
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Regulatory Compliance
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Provides support and oversight for the preparation for local authority GxP and Pharmacovigilance inspections in Asian affiliate offices.
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Approval of SOPs and associated process documentation as required of regulatory affairs, internally and externally.
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Act as Records Retention coordinator for the appropriate maintenance and storage of information according to agreed records retentions schedules for regulatory affairs for the Asian Regional Office.
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Drive implementation of agreed policies and processes for the Asian Region.
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Pricing & Reimbursement
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Provide regulatory guidance and input as required to support our client?s pricing strategy and negotiations with the authorities in order to obtain optimum pricing.
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Prepare or oversee preparation of required regulatory documentation to support the agreed pricing and reimbursement strategies.
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Pharmacovigilance Responsibility
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Ensure that pharmacovigilance activities are undertaken in line with applicable roles and responsibilities, and conform with SOPs and Safety Data Exchange Agreements.
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Management and Administration
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Perform all required reporting obligations.
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Manage and lead direct report(s) in allocation of work, the performance of their duties and for their training and career development.
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Provide input for performance review and talent mapping/development.
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When applicable, recruit staff.
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Support the individuals and teams in other functions in the performance of their duties for the Asian Region as required.
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Provide Regulatory Affairs input to crisis and incident management and business continuity planning and events, as required.
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Encourage sharing of best practice between Asian affiliate offices and central regulatory teams.
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Effective member of the Asian Regional Office Management Team.
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Key Performance Indicators
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Set up the Regulatory function in Asia as part of International Regulatory Affairs and International business.
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Establish standard operating procedures and any required licences to enable the function and business, as appropriate for Regulatory Affairs, to conduct business in compliance with internal and external standards.
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Establish working relationships with our client?s commercial partners in Asian territories to maximise commercialisation of their product portfolio.
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Become familiar with the organisation, its people, its portfolio and its ways of working.
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Establish excellent working relationships with colleagues in the Asian Regional Office, Asian Affiliate offices.
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Attend and participate in required meetings.
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Candidate Profile
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Work Experience & Abilities Required:
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Must have an extensive knowledge of regulatory requirements, including ICH requirements and national requirements for markets in the Asian Region and have an understanding of current global, regional and national trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
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Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
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Demonstrated ability to act as primary contact with Regulatory Authorities.
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Ability to manage complex relationships with distributors and agencies with the required tenacity and flexibility of style.
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Must be capable of taking a leadership role in providing regulatory advice and in updating and preparing our client for changes in legislation in assigned territories.
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Previous people management experience and direct experience working with Regulatory Authorities in assigned territories (Asia) is required.
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Experience required in pharmacovigilance, in regulatory systems / IT and in representing Regulatory Affairs on project teams.
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Personal Qualifications:
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Business / commercial acumen.
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Excellent interpersonal skills.
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Excellent organisation skills and ability to work on a number of projects with tight deadlines.
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Excellent negotiation and influencing skills.
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Excellent teamwork skills.
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Leading and managing teams (both in-situ and remotely).
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Must be able to facilitate effective interactions within International Regulatory Affairs and with other departments and sites within the company, and with external organisations such as national authorities, trade associations and professional bodies.
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Competencies
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Information seeking.
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Problem solving.
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Planning.
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Business awareness.
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Impact and influence.
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Initiative.
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Leadership.
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Strategic thinking.
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Results driven.
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Customer focus.
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Self development.
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Education:
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Requires a BSc/BA degree in a relevant discipline and minimum 12 years of relevant experience in Regulatory Affairs.
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Language Abilities:
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Must be fluent (verbal and written) in English. Knowledge of local languages used in Asia is desirable.
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For more information regarding this position, please contact Mr. Vache Petrossian at vache@fosterpartners.com.cn
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The recent struggles of a family to collect a $200-million verdict against a Florida nursing home highlight the difficulty that plaintiffs frequently face in getting the money that a jury has ruled is theirs.
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Public release date: 24-Feb-2012
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