VP, Global Regulatory Policy
Location: Cambridge Massachusetts
Description: Biogen Idec is in need of VP, Global Regulatory Policy right now, this career will be placed in Massachusetts. For complete informations about this career opportunity kindly see the descriptions. The VP Global Regulatory Policy will provide the leadership and strategic direction to global regulatory policy organization and BIIB. The VP will be a strong subject matter expert in regula! tory processes, laws, and regulations, with a strong understanding of how regulatory policy is shaped and developed. The VP will build and manage a highly collaborative function that addresses global intelligence gathering, analysis of changes in the regulatory environment, development of policy positions, and creation and execution of advocacy strategies to achieve policy goals, working collaboratively with both internal and external stakeholders to influence the policy environment set by global regulatory authorities (ie FDA, EMEA, CHMP, etc. The VP will be responsible for overseeing the creation and implementation of systems/processes to monitor the regulatory environment for changes, and to work with subject matter experts within the company to assess impact on BIIB’s products and goals. The VP requires strong relationship management and interpersonal skills in order to partner effectively with key stakeholders and leaders internally (Regulatory, Government Affairs, L! egal, Development) and externally (regulatory groups within tr! ade associations) to influence strategic direction of complex global regulatory policy issues.
Provides oversight and strategic direction to BIIB’s efforts to influence regulatory policy globally (US, EU, Japan, ROW). Leads advocacy efforts within BIIB to influence global regulatory authorities in the development and implementation of emerging regulatory policy. Provides subject matter expertise on emerging regulatory issues and how Biogen Idec can engage to influence policy outcomes.
Responsible for overseeing and leading the creation and implementation of systems/process to monitor the changes to the regulatory environment. Oversees the work of internal staff and outside consultants to compile a comprehensive picture of regulatory policy in individual countries and regions, including analyses of issues and their impact on the company’s product portfolio. Oversees the evaluation of all proposed regulations and policies issued by national/regional regu! lators (FDA, EMA, JPMA, etc) and the development and submission of BIIB’s written responses, along with BIIB’s input to the trade associations regarding their responses to policy proposals. Works with SMEs across the company to analyze impact of policy proposals, determine our preferred policy position, develop and execute a regulatory advocacy strategy.
Serves as the main point of contact for BIIB with the policy-making staff at key regulatory agencies (FDA, EMA, etc) on issues related to broad policy and provides guidance for company relationships with other regulators, and oversees consultants to further expand these relationships, particularly in emerging markets. Builds and maintains relationships with key agency staff to improve Biogen Idec’s ability to engage with regulatory policy making. Fosters relationships with affiliated stakeholders to support BIIBs goals and objectives. Participates in industry forums to advance BIIB’s regulatory policy goals! . Conceives of and executes strategic creative methods for advancing re! gulatory policy goals, including the development of coalitions with other companies, engagement in professional societies, development of symposia, and scheduling of site visits and high level meetings with policy makers.
Works in collaboration with other functional leaders in Regulatory on regulatory policy issues that effects the portfolio. In addition, collaborates closely with Government Affairs and other key stakeholders within BIIB on the development and implementation of regulatory policy goals. Coordinates closely with Government Affairs on advocacy activities to ensure a consistent approach across regulatory, administrative, and legislative arenas. Serves as the key point of contact or his/her delegate for Government Affairs by coordinating regulatory staff’s timely evaluation of and input on the regulatory impact of legislative policy proposals.
Provides staffing to key members of the R &D organization, and other groups as appropriate, regardin! g trade association efforts on regulatory matters. Provides coordination and oversight for BIIB’s representatives on technical working groups at trade associations and other venues to ensure that BIIB’s representatives are advancing BIIB’s policy agenda in these forums and reporting back as appropriate to their peers. Represents BIIB in key trade association forums on regulatory matters as appropriate, working closely with Government Affairs to coordinate trade association engagement to ensure a unified voice for the company.
Responsible for building BIIB’s global regulatory policy team. Leads and manages global regulatory policy staff by providing direction and mentorship.
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Significant experience ( 10 + years) working in Regulatory Policy either within a Regulatory Agency and/or in the Biopharmaceutical Industry. Education Minimum of a Bachelor’s Degree (B.S. or B.A.) in biological sciences, or related field. Advanced degree preferred.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Biogen Idec.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Thu, 07 Nov 2013 20:44:05 GMT
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