Director, Global Regulatory Affairs Lead (Oncology)

The role is responsible for line management of Global Regulatory Strategy (GRS) Therapy group (TG) staff and may also involve individual support for projects as a regional director or GRL.  The role reports directly to the GRS TG Portfolio Lead.  The Regulatory Director/Team Leader along with the respective Portfolio lead is responsible for:

• Provision of adequate resources to support the various development programs within the respective portfolio.
• Ensuring the development and effective execution of regulatory strategies for assigned assets. These strategies must be aligned with the Medicines Development Strategy and the Integrated Evidence Strategic (IES), ensuring that the development program fulfills the requirements of key markets as identified and the Medicine Profile.

All regulatory activities and line management must be carried out in strict compliance with internal GSK processes and policies, as well as with applicable regulatory requirements.

Leadership Responsibilities include but are not limited to:

Management of direct reports.

This requires mentoring/coaching of Team members, guidance to ensure successful implementation of regulatory strategies and adherence to all relevant internal and external standards and practices. 

The position may also involve individual support for projects as a regional director or GRL.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Accountable to GRS TG Portfolio Lead and TG VP for development of appropriate regulatory strategy(s) and for delivery according to plans.  In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to the TG VP level.  Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile. Resourcing includes recruitment of new staff. Work closely with the Portfolio Lead to develop coach/mentor individuals within the team including performance assessment/management. May also be responsible as a regional director or GRL for select asset(s)

When a Team Lead (as applicable):

• Provides direct line management responsibility for TG staff.
• Ability to attract talent, challenge and manage and develop direct reports.
• Manage performance for direct reports (e.g. My Plan, Reward, Recognition, PIPs, etc.)
• Drives specific topics such as resource demands and workforce planning.
• Understands well and is able to drive resource management conversations including new assignments, gap identifications, while taking into account individuals’ needs.
• Assist in managing TG budget.

When a GRL(as applicable):

• Works with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program. If prioritized by the MDT, works closely with the global commercial team and local regulatory teams in prioritized countries to secure the best possible labelling commensurate with available data and in line with the GDS.
• Proactively develop regulatory strategy and promote innovative regulatory approaches when they benefit advancement of a given program.  Ensure implementation of the regulatory strategy(s) in support of the project priorities.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
• Lead regulatory interactions and the regulatory review processes.
• Ensure effective interaction with local regulatory counterparts in priority markets and global commercial teams, as applicable.
• Ensure compliance with regulatory requirements at all stages of product life.
• Advocate persuasively to senior leaders in GSK and in Health Authorities.
• Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).
• Act as single point of accountability on the EDT/MDT, lead the Regulatory Matrix Team, and deliver the required Regulatory Work Package(s) associated with the IES.

When a Regional Director (as applicable)

• Accountable to GRL and/or Portfolio Lead and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies).
• In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
• Ensure the regulatory strategy will deliver the needs of the local region(s), taking into account the needs of other regions globally
• Implement the regional strategy(s) in support of the project globally
• Lead regulatory interactions and the review processes in local region
• Ensure appropriate interaction with regional commercial teams in local region
• Ensure compliance with regional requirements at all stages of product life from C2MD
• Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
• Capable of providing critical regulatory assessment as part of due diligence/business development activities.

Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
• 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry. (The source calls for extensive regulatory experience across all phases of development).
• Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings.
• Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
• Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
• Experience ensuring compliance with applicable regulatory requirements,
  industry standards, and company policies throughout the product lifecycle.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Advanced degree (PhD, MD, PharmD, or relevant master’s degree) in biology, Life Sciences, Healthcare Sciences.
• Experience in resource management and forecasting.
• Experience in all phases of the drug development process in regulatory affairs, including projects where there is little or no precedence. 
• Knowledge of relevant therapeutic areas or proven track record of being able to develop product.
• Knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally.  Ideally, proven experience of leading regulatory activities outside local region.
• Experience as a Global Regulatory Lead or equivalent leadership role.

#Li-GSK

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management

 

 

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $171,750 to $286,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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