Head of Regulatory Affairs and Pharmacovigilance Operations

Job Description

Head of Regulatory Affairs and Pharmacovigilance Operations

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), the Head of RAPV Operations is a member of the RAPV leadership team (RAPV LT). In this capacity, he/she participates in the creation and execution of the mission, objectives, and mid-term strategic planning for the RAPV Functional Unit, and ensures the effective translation and execution into annual functional operational plans such that PV RA strategic goals are achieved.

The RAPV Operations Head is accountable for ensuring the optimal development, allocation and global management of PV and RA operational staff, and for excellence in the development and maintenance of processes and systems, to ensure the execution of worldwide safety data processing and submission, regulatory publishing and submissions, and regulatory product information management in a manner compliant with internal operating procedures and regulatory requirements.

Additionally, the Head of RAPV Operations provides strategic process leadership and expertise to the RAPV management team and executive leadership on operational matters relating to Pharmacovigilance and Regulatory Affairs.

Essential Job Responsibilities:

• Participates in the development and implementation of 3-5-year RAPV Mission, vision and strategic objectives, develops 1-3 year strategic and operational plans that align to the RAPV vision, and is accountable for the successful achievement of annual objectives.
• Responsible for optimizing RA and PV Operations, setting the 1-to-3-year strategy for execution of RA PV operational activities, and determining how the strategy is deployed.
• Accountable to develop PV processes that allow for high medical quality and strict regulatory compliance with safety data handling and worldwide reporting, including the collection, assessment, coding and reporting of safety information from a variety of sources, as required by worldwide regulations. Provides strategic process leadership and support to the PV operational leads on matters relating to Pharmacovigilance; drives the strategic direction for case processing and vendor ICSR management; is accountable for designing and establishing the best practices for case processing in line with the highest quality, timeliness and efficiency standards.
• Accountable for the oversight of PV technological systems/applications, including the global safety database, to ensure regulatory compliance and support the business needs for data analysis.
• Leads the strategic direction for PV automation to ensure state of the art business processes and operations.
• Established the strategy and direction of Astellas' regulatory submissions technologies, systems, processes, electronic tools, and standards that reflect excellence in global regulatory standards and enable the quality and timeliness of regulatory submissions to health authorities and the internal electronic records of the submissions.
• Supports Regulatory Authority inspections and drives the resolution of inspection issues pertaining to PV or RA operational activities. Accountable for definition and implementation of corrective and preventive actions owned by RAPV Operations.
• Interprets regulations across multiple disciplines in consultation with business, legal and R D functions, recommends next actions and sponsors the implementation of process improvement initiatives to secure compliance with new regulations.
• Responsible for the effective implementation of optimal organizational structure(s) which maximizes on the use of resources globally and reflects business needs and conditions. Develops an environment to enable each member of RAPV operations to optimally operate in a matrix environment. Manages the RAPV operations function and its people, through successful recruitment, performance management, development planning and retention of a high performing team. Effectively delegates responsibilities to achieve RAPV operations goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.

Requirements

Qualifications Required:

• Advanced degree in scientific discipline required.
• Minimum of 15 years' experience in PV Operational role, including experience in a senior leadership position. Proven track record of leadership and operational experience in the pharmaceutical industry, particularly with respect to pharmacovigilance compliance requirements.
• Demonstrated technical, compliance and problem-solving skills including an understanding of regulatory requirements, and experience in managing regulatory compliance (with in-depth knowledge of ICH, GMPs, GCPs, GLPs and good Pharmacovigilance practices), product safety reporting, electronic data management/document management/publishing. Proven experience with establishing and maintaining (GxP) Quality Management System.
• Experience leading in a multi-national environment.

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.

Preferred:

Experience in regulatory operations (publishing, submissions, or product information management) strongly preferred.

Salary Range
$400-$475K (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