Director, Global Regulatory Science and Policy at Sanofi Pasteur in Becket, MA
The Director will be a strong subject matter expert in regulatory processes, laws, and regulations, with a strong understanding of how regulatory policy is shaped and developed. He/She will work closely with subject matter experts within our company to assess the impact of regulatory policy on the company's products and goals.
Responsibilities:
Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact Sanofi's R&D pipeline, regulatory strategy or product portfolio. Provide regulatory intelligence to internal stakeholders, including GRA, R&D, Government Affairs, Medical Affairs and Legal. Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on Sanofi's products and goals. Coordinate and lead internal teams to develop Sanofi responses and comments on draft legislation, regulations, guidelines and regulatory policies issues. Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on Sanofi position. Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters. Lead proactive advocacy efforts for Sanofi's priority regulatory policy areas. Consult with internal experts and leadership to identify priority issues. In collaboration with GRSP team, internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies. Serve as key liaison, and represent Sanofi as assigned, with trade associations, think tanks, advocacy organizations and regulatory authorities, managing and guiding the strategy for and execution of these interactions. Provide support and leadership on additional projects concerning the development, status and impact of regulatory policy issues. Produce regulatory intelligence reports or deliverables as it relates to project or process strategies to further regulatory strategy and decision-making. Prepare and deliver regulatory intelligence alerts, summaries, reports and newsletters on regular schedule highlighting pertinent regulatory activities and potential impact on Sanofi products and businesses. Maintain consistent oversight of deliverables and ensure issues are escalated when needed and encourage resolution at the appropriate level. Play a key role in development and implementation of appropriate systems, processes and standards within Regulatory Science and Policy and within GRA and Sanofi as assigned. Act consistently with Sanofi best practices and code of ethics. Education, Experience and Skill Requirement:
Advanced degree in life sciences, or law; or equivalent experience in pharmaceutical industry or science policy. 5
to 10
years' experience, depending on level, in the pharmaceutical space, either within government, industry, or consultants. Extensive and proven expertise in healthcare regulatory environment. Familiarity and understanding of the drug/biologic development and commercialization process. Previous experience working with senior-level members or officials of trade associations or other key groups that influence regional policies. Impeccable ethics and proven ability to demonstrate Sanofi values. Proven leadership skills. Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment. Ability to lead multiple complex initiatives (short, mid and long-term). Superior time management and organizational skills. Excellent business acumen and strategic agility. Critical thinker. Good judgment and decision making abilities. Excellent written, oral, and presentation communication skills; Excellent command of English (written and spoken) Proven success at stakeholder engagement across organizational levels and boundaries with ability to manage highly complex situations and engender trust when dealing with sensitive issues
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact Sanofi's R&D pipeline, regulatory strategy or product portfolio. Provide regulatory intelligence to internal stakeholders, including GRA, R&D, Government Affairs, Medical Affairs and Legal. Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on Sanofi's products and goals. Coordinate and lead internal teams to develop Sanofi responses and comments on draft legislation, regulations, guidelines and regulatory policies issues. Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on Sanofi position. Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters. Lead proactive advocacy efforts for Sanofi's priority regulatory policy areas. Consult with internal experts and leadership to identify priority issues. In collaboration with GRSP team, internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies. Serve as key liaison, and represent Sanofi as assigned, with trade associations, think tanks, advocacy organizations and regulatory authorities, managing and guiding the strategy for and execution of these interactions. Provide support and leadership on additional projects concerning the development, status and impact of regulatory policy issues. Produce regulatory intelligence reports or deliverables as it relates to project or process strategies to further regulatory strategy and decision-making. Prepare and deliver regulatory intelligence alerts, summaries, reports and newsletters on regular schedule highlighting pertinent regulatory activities and potential impact on Sanofi products and businesses. Maintain consistent oversight of deliverables and ensure issues are escalated when needed and encourage resolution at the appropriate level. Play a key role in development and implementation of appropriate systems, processes and standards within Regulatory Science and Policy and within GRA and Sanofi as assigned. Act consistently with Sanofi best practices and code of ethics. Education, Experience and Skill Requirement:
Advanced degree in life sciences, or law; or equivalent experience in pharmaceutical industry or science policy. 5
to 10
years' experience, depending on level, in the pharmaceutical space, either within government, industry, or consultants. Extensive and proven expertise in healthcare regulatory environment. Familiarity and understanding of the drug/biologic development and commercialization process. Previous experience working with senior-level members or officials of trade associations or other key groups that influence regional policies. Impeccable ethics and proven ability to demonstrate Sanofi values. Proven leadership skills. Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment. Ability to lead multiple complex initiatives (short, mid and long-term). Superior time management and organizational skills. Excellent business acumen and strategic agility. Critical thinker. Good judgment and decision making abilities. Excellent written, oral, and presentation communication skills; Excellent command of English (written and spoken) Proven success at stakeholder engagement across organizational levels and boundaries with ability to manage highly complex situations and engender trust when dealing with sensitive issues
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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