Head of Regulatory Affairs and Pharmacovigilance Affiliates- United States

Head of Regulatory Affairs and Pharmacovigilance Affiliates – United States

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose And Scope

Reporting to the Head of Regulatory Affairs and Pharmacovigilance (RAPV), and as a member of the RAPV Leadership Team, the Head of RAPV Affiliates - United States will help to define and execute the RAPV Mission, annual objectives and 3–5-year mid-term strategic plan, to ensure the effective translation and execution of regulatory and safety deliverables to meet strategic Enterprise goals.

This role serves as the RAPV Site Head for the US and a key point of contact for executive management and US-based Astellas senior leaders for local regulatory and safety issues concerning US marketed products. This role has accountability for overall leadership, regulatory compliance and operational success for affiliate Regulatory Affairs and Pharmacovigilance function in the United States, including the US advertising and promotion activities, and local safety activities of designated pharmaceutical products. The role also serves as the primary contact for US Food and Drug Administration (US FDA) administrative (non-product related) queries and activities.

Principal contacts include RAPV Leaders in Regulatory Strategy Medical Safety and Safety Sciences and Labeling; US Affiliate leaders in Medical Affairs, Marketing and Sales, Legal, Business Partners, and Regulatory Authorities and Key Opinion Leaders in United States/ Americas business region.

Essential Job Responsibilities

Activities under the responsibility of the RAPV Affiliate Head for the United States include:

• Participates in the development and implementation of the RAPV mission, vision, and strategic objectives, develops 1-3 year strategic and operational plans which align to this vison and is accountable for the successful execution and achievement of annual strategic goals.
• As the RAPV senior representative to the US Brands@Center Board of Directors, serves as the senior local regulatory and safety liaison to facilitate alignment between the global RAPV teams and the US Commercial and Medical Senior Leadership. Partners with the global Regulatory Strategy and Medical Safety Heads, as well as other R&D, Medical and Commercial leaders, to support post marketing US RA and PV strategy, positioning Astellas for sustainable success with Health Authorities in the regional business. Influences Development processes and policy associated with post-registration activities.
• Accountable for the regulatory oversight of US Commercial advertising and promotion activities to ensure full compliance with local regulatory requirements, as well as ensuring regulatory alignment with development and business goals. Escalates risk determinations for US ad Promo materials, as needed. Provides attestation of compliance with annual PhRMA/Code of Conduct for Astellas US Ad Promo materials.
• Sets the strategy for, and ensures execution of, safety surveillance and operational activities in the US affiliate, to ensure compliance with US regulations.
• Ensures the compliant execution of patient safety information training (i.e., AE Awareness training) for Astellas employees within the US organization.
• Serves as the primary point of contact for administrative (non-product) interactions with FDA, including but not limited to:
• Ensuring payment of CDER Collections (FDA User fees), such as annual PDUFA program fees, and other US FDA or WHO payments (USAN generic drug names)
• Serving as primary contact for the FDA Drug Shortages Group to address FDA queries concerning product availability (e.g., with patient/ provider reported access issues or generic competitor supply issues).
• Astellas signatory / certifier on Corporate Integrity Agreements.
• Supports cross-functional discussions of Significant Quality Issues (SQIs), particularly with respect to FDA reporting requirements.
• Member of the US Commercial Compliance Committee.
• Partners with internal Global Regulatory Policy and Intelligence group and US Government Affairs to continually monitor and analyze US regulatory agency activities in areas concerning the company’s marketed products and advises Astellas Senior Management on necessary actions to develop and support a best-in-class Regulatory Affairs organization. Advises senior management on regional regulatory agency actions that could impact the business and partners with Legal and external committees/trade associations to influence policy change. Interacts with senior management to affect internal policy and strategies for risk assessment, management, and control of promotional content.
• Supports local regulatory inspections and oversees resolution of identified inspection issues. Accountable for definition and implementation of corrective and preventive actions owned by the US RAPV team.
• Serves as an executive sponsor of 2-year post-PharmD Fellowship.
  
  

People and Organizational Management

• As a member of the RAPV leadership team, contributes to the development and implementation of optimal organizational structures for RAPV and for the successful management, leadership and oversight of competency, capabilities, and performance throughout the regions, and maximizes the use of resources and reflects business needs and conditions. Develops an environment to enable each member of the regional team to operate optimally in the matrix environment of RAPV and Astellas.
• Leads the RAPV US function and fosters an environment of collaboration, trust, regulatory and scientific excellence, innovation, pro-activity and a commitment to professional staff recruitment and development.
• Effectively delegates responsibilities to achieve functional and sub functional goals, while simultaneously developing individuals to grow and deliver to the best of their abilities through optimal oversight and supervision.
• Responsible for the development and maintenance of effective collaborations with internal and external regional stakeholders and functions.
• Sponsors and is accountable for the development and implementation of talent management initiatives to ensure core competencies are developed throughout the RAPV function.
• Responsible for creating and leading a culture that models ethical and compliant behavior.
  
  

Qualifications Required

• Bachelor's Degree is required, and an advanced degree in a scientific discipline (MD/DO, PharmD, PhD, etc.) strongly preferred.
• Minimum of 15 years’ experience in pharmaceutical drug development (including senior leadership position(s)), with a minimum of 10 years in regulatory affairs and/or pharmacovigilance.
• Demonstrated scientific knowledge in the life, physical or health sciences. Solid basis in scientific approach and ability to deal with in-depth technical information for a variety of disciplines and foster a high degree of scientific credibility with regulatory agencies and within Astellas.
• In depth understanding of US 21 CFR safety regulations for both marketed and investigational products, as well as ICH, and high-level understanding of EU GVP and Japanese regulations.
• Proven track record of leadership and operational experience in the pharmaceutical industry within the assigned area. Proven track record in leading an organization in R&D, with demonstrated exceptional interpersonal skills and ability to resolve conflict and take decisions. Proven track record in leading interactions with regulatory authorities.
• Demonstrated understanding of pharmacovigilance regional requirements in safety data collection and reporting, and ability to articulate key safety concepts of signal detection, risk management and medical safety topics.
• Travel to one of the corporate sites, may periodically be required, as reflects the business needs.
• Demonstrated excellence in the following
  
  

Leadership Capabilities

• Strategic Orientation: Ability to drive towards future state objectives by understanding environmental challenges, linking vision to daily tasks, identifying value creation opportunities, and influencing culture.
• Critical Decision Making: Proven ability to drive evidence-based decisions related to patient safety.
• Proactive Issue Identification and Escalation: Demonstrated ability to anticipate, recognize and communicate issues proactively and to effect timely and satisfactory resolution.
• Communication: Excellent communication and presentation skills in English (written and spoken).
• Social Intelligence: Superior interpersonal skills, with a demonstrated ability to resolve conflict, think strategically and tactically, generate solutions to complex problems and build consensus/ influence others.
• Executive Presence: Demonstrated ability to project clarity, credibility, confidence, composure, connection and charisma, inspiring trust with teams, peers, external Stakeholders and Top Management.
• Developing Teams/ People: Ability to get the best out of teams through open communication, regular feedback, recognition, empowerment, offering growth opportunities, creating a positive culture, and leading by example.
• Enterprise Mindset: Demonstrated ability to focus on organizational outcomes and goals above individual/ functional outcomes.
• Resilience: Ability to deliver under significant pressure and enable team resilience.
• Budget Management: Experience in planning, allocating and managing multiple project or departmental budgets.
  
  

Salary Range

$375K – $440K (NOTE: Final salary could be more or less, based on experience)

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program
  
  

Category Affiliate Management

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans