Director, Global Regulatory Strategy

GlaxoSmithKline; Rockville (MD); Híbrido; USD 172.000 - 286.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement benefits

Paid time off

Descripción de la vacante

GlaxoSmithKline is seeking an experienced Regulatory Leader to join Global Regulatory Strategy, supporting Respiratory, Immunology and Inflammation assets. You will develop and execute global regulatory strategies and provide leadership to cross-functional teams.

You will lead health-authority interactions, regulatory submissions, and strategic development plans while ensuring lifecycle compliance across regions. Hybrid work options available, with global scope and complex programmes.

Formación

• Bachelor's degree or equivalent in biological science, healthcare science or related discipline.
• Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle.
• Experience developing and delivering regulatory strategies for development programmes.
• Experience leading regulatory submission and approval activities.
• Track record of leading health-authority interactions or milestone meetings.
• Experience providing regulatory leadership within global, cross-functional matrix teams.
• Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets and a global regulatory environment.

Responsabilidades

• Develop and execute global and regional regulatory strategies for assigned assets.
• Ensure regulatory strategy aligns with medicines development plans and priority markets.
• Provide strategic regulatory leadership to cross-functional teams and be accountable for assigned assets.
• Assess regulatory precedent, intelligence and competition to inform strategy.
• Lead regulatory matrix teams and coordinate regulatory activities across functions and geographies.
• Lead health-authority interactions, submissions and milestone meetings.

Conocimientos

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Policy Advocacy

Regulatory Strategies

Resource Management

Stakeholder Management

Educación

Bachelor's degree or equivalent in biological/healthcare sciences

Master's degree or PhD (advanced qualification)

Descripción del empleo

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Position Summary

We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory, Immunology and Inflammation portfolio.

What you'll do

• Develop and execute innovative, evidence-based global and regional regulatory strategies for assigned Respiratory, Immunology and Inflammation assets.
• Ensure regulatory strategy is integrated with medicines development plans, evidence-generation strategies and the requirements of priority markets.
• Provide strategic regulatory leadership to cross-functional development teams and act as a key point of accountability for assigned assets.
• Assess regulatory precedent, intelligence and the competitive environment to identify opportunities, risks and implications for development strategy.
• Translate complex scientific and regulatory information into clear recommendations that enable timely, well-informed decisions.
• Lead regulatory matrix teams and coordinate delivery of regulatory activities across functions and geographies.
• Lead health-authority interactions, regulatory submissions, milestone meetings and review processes.
• Partner effectively with clinical development, safety, medical, commercial and local regulatory colleagues.
• Develop regulatory approaches that support appropriate labelling based on the available evidence and applicable regulatory requirements.
• Anticipate regulatory risks and develop practical strategies to address them.
• Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
• Represent regulatory perspectives with senior leaders and health authorities, advocating clearly and credibly for evidence-based approaches.
• Contribute regulatory expertise to due-diligence and business-development activities where required.
• Identify opportunities to use digital capabilities and new approaches to strengthen regulatory decision-making and improve efficiency.

Basic qualifications and experience

• A bachelor's degree or equivalent relevant professional experience in biological science, healthcare science or a related discipline.
• Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle.
• Experience developing and delivering regulatory strategies for development programmes.
• Experience leading regulatory submission and approval activities.
• A track record of leading interactions or milestone meetings with health authorities.
• Experience providing regulatory leadership within global, cross-functional matrix teams.
• Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets, together with a sound understanding of the global regulatory environment.

Preferred qualifications and experience

• A master's degree, PhD or other advanced scientific or regulatory qualification.
• Regulatory experience supporting Respiratory, Immunology and Inflammation medicines or development programmes.
• Experience acting as a Global Regulatory Lead, Regional Regulatory Director or in a comparable strategic regulatory role.
• Experience leading regulatory activities across multiple geographic regions.
• Experience working across different stages of development, from early development through registration and lifecycle management.
• Experience leading regulatory strategy where there is limited precedent or significant scientific complexity.
• Strong influencing and communication skills, including the ability to make complex regulatory issues clear to different audiences.
• Demonstrated ability to build effective relationships and influence decisions without formal authority.
• A strong commitment to quality, ethical conduct and compliance with applicable laws, regulations and company requirements.
• Strong clinical and scientific understanding of drug development.
• Experience applying regulatory intelligence, data or digital approaches to development and regulatory decision-making.
• Experience providing regulatory input to due diligence, licensing or business-development evaluations.

Work Location and Working Style

This position is based in the United Kingdom, US, or Belgium and offers a hybrid working model. We encourage a balance of working from our office and remotely, giving you flexibility to manage your work-life needs.

Why join us?

This role provides an opportunity to shape regulatory strategy across the Respiratory, Immunology and Inflammation portfolio and influence the development of medicines from a global perspective. You will work at the centre of multidisciplinary development decisions, engage with health authorities and senior stakeholders, and provide regulatory leadership on scientifically complex programmes.

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, 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 $171,600 to $286,000. 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.Belgium Salary Range / Fourchette salariale - Belgique: EUR 111,750 to EUR 186,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/