This position serves as a key strategic partner with the Business Unit and the relevant Medicines Development Team (MDT). The individual will serve as the Regulatory Lead on the Business Unit Leadership Team and lead the regulatory matrix team for each assigned asset. They will be accountable to the Director of Global Regulatory Development for the development of the global and/or regional regulatory strategy for the assigned assets that is aligned to the business unit.
This this position will also provide high level strategic guidance for the review and approval of FDA-compliant commercial advertising and promotional campaigns and pre-commercialization activities for the Business Unit products.
The responsibilities of this job include, but are not limited to, the following:
Provide strategic regulatory input into the Business Unit and serve as the regulatory functional lead on the Business Unit Leadership Team.
Serve as the Regulatory Lead on the Medicines Development team for assigned development projects and marketed products within the Business Unit.
Contribute to the creation and implementation of development plans that incorporate regulatory strategies designed to optimize the regulatory pathway, maximize the likelihood of successful regulatory applications, delivering regulatory approval and reimbursement for key indications and optimizing the label to differentiate product claims.
Lead the preparations and interactions with Health Authorities in conjunction with the Medicines Development Team (MDT) for assigned projects.
Lead the global regulatory affairs matrix team to integrate the input from CMC Regulatory, Labeling, Regulatory Operations and Regional Regulatory Affairs into the global regulatory strategy for each assigned asset.
Provide interpretation of health authority regulations, policies and guidelines to the MDT in alignment with the global regulatory affairs matrix team.
Responsible for keeping leadership team informed of regulatory status of project and any risks/issues that arise. With the MDT develop and implement risk mitigation strategies as appropriate.
Provide regulatory due diligence into business opportunities, as needed.
Deliver all regulatory related activities in compliance with the regulations and Indivior policies / procedures.
Lead or assist with other projects and activities as assigned by the global regulatory affairs leadership team.
Provide expert guidance related to promotional regulatory strategy to Medicine Development teams and the Business Unit during the clinical development process to optimize the delivery of differentiating labeling claims.
Ensures submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities in alignment with Indivior expectations and target deliver dates.
Education: Bachelor’s degree required
Master’s Degree, PharmD or PhD in a biomedical science preferred
Experience: A minimum of 10 years of pharmaceutical industry experience required with 5 years in a Regulatory Affairs leadership role.
Computer Skills: Proficient in Microsoft Office and regulatory archive and promotion review software
Regulatory Affairs Certification (RAC)
In addition to the minimum qualifications, the employee will demonstrate:
Strategic thinking with a bias for strong results-orientation with demonstrable track record of success
Excellent interpersonal skills / leadership presence and ability to engage with Regulators, global regulatory affairs team and Cross Functional Management & Commercial Teams
Demonstrated track record of working on global teams and a matrix organization.
Substantial experience integrating regulatory science with general pharmaceutical / biomedical knowledge and business acumen in order to develop and implement innovative approaches to drug development and registration.
Excellent written and verbal communication skills
Demonstrate high levels of energy and drive; ability to set and deliver challenging targets.
Confidence to challenge the status quo, to speak up and to manage and deliver change.
and comfortable in a fast-paced, changing and dynamic environment
Self-motivated and highly flexible - Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities
Experience leading and developing/mentoring junior staff
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
Internal Number: R301
Indivior is the world leader in opioid addiction treatment and our vision is for all patients around the world to have access to quality treatment for the chronic relapsing condition and co morbidities of addiction.