Job Abstract

Job Description

The Global Regulatory Policy & Intelligence (GRPI) team advocates for regulatory policy that supports our company’s business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical leader.  We work in partnership with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement a prioritized plan for policy that advances business goals. 

Our GRPI team responsibilities include:

• Developing and delivering world-class regulatory policy service for all business segments and regions.
• Proposing - and responding to - regulatory guidance and action.
• Advocating for and anticipating regulatory change with globally leading regulators and multilateral organizations.
• Providing insights and advocating for positions on critical regulatory issues and trends.
• Building our company’s share of voice and influence extramurally to support the company's enterprise policy agenda.

Responsibilities of the Director, US Regulatory Policy, will include:

• Proactively monitoring emerging scientific and regulatory trends/strategies, both internally and externally, to shape and influence changes in the global regulatory environment. 
• Serving as subject matter expert in FDA internal practices and external policies, regulatory processes, laws, and regulations, for assigned areas, with a strong knowledge of how regulatory policy is shaped and developed in the United States.
• Representing the company in assigned areas on industry committees, with agility to cover areas outside those assigned as needed and/or as pipeline needs change.
• Maintaining productive relationships with industry staff and global regulators to ensure productive Agency interactions; fostering internal relationships to ensure company needs can be gauged and understood to facilitate both external advocacy and internal implementation.
• Planning and managing GRPI interactions with our Research and Development Division's colleagues, regulatory liaison staff, and local regulatory affairs staff for submission of product applications and other related interactions with Health authorities.
• Monitoring emerging regulatory policy issues in assigned areas, including issues arising from global regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identifying those issues likely to impact the company’s regulatory strategy or product portfolio.
• Leading internal teams as assigned to address regulatory policy issues.  Assignments will evolve over time to meet business objectives and programmatic needs, and Director’s areas of expertise.
• Coordinating appropriate internal staff to develop company responses to draft legislation, regulations, guidance, and other regulatory policy documents.
• Planning and managing interactions and communications with trade associations and health authorities on regulatory policy matters.
• Participating in regulatory project teams to help develop regulatory strategies based on knowledge of FDA requirements, guidance, policies, and procedures.
• Participating in regulatory staff meetings to learn about product matters likely to surface which may require involvement/action of the GRPI staff.
• Managing activities for select meetings with FDA and other health authorities (e.g., regulatory milestone meetings, management “meet and greets”, ad hoc policy-focused meetings) as assigned for specific projects. 
• Maintaining liaison with outside scientific and professional organizations to represent the company on product and regulatory policy matters under the supervision of the Executive Director, US Lead, US Regulatory Policy.
• Participating in industry and professional meetings to maintain competency on regulatory policy issues.
• Participating in industry and professional meetings to actively advocate for company-specific or Industry-wide issues.

Education Requirement:

• Bachelor’s Degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a Master’s or Doctorate degree in science, health care, public health, health policy, or law
• Doctorate degree and at least 5 years’ experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR
• Master’s degree and at least 8 years’ experience with FDA or other health authority, either directory (working within a health authority) or indirectly (closely interacting with health authority) OR
• Bachelor’s degree and at least 10 years’ experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority)

Qualifications Required:

• Proven capability in acting as a credible, influential and respected spokesperson able to convey complex messages, trends & insight
• Deep understanding of the US regulatory environment, the Food, Drug and Cosmetic Act and latest regulations and guidance's with sound knowledge of intelligence tools and methods; preference will be given to candidates with experience supporting therapeutic product applications and submissions to health authorities, or similar background in regulatory strategy .
• Strong relationship management and interpersonal skills with superb written and oral and communication skill
• 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
• Ability to fully demonstrate our company leadership principles, driving results and building talent.
• Ability to thrive in a cross-functional team environment with a global mindset
• Ability to travel internationally
• Excellent command of English (written and spoken)

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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