Director, Global Regulatory Affairs

1 week ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Home Worker - USA, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, USA - Massachusetts - Waltham
Posted Date: Jul 1 2024

The Director of Regulatory Affairs-Oncology will be a ccountable to the GRL and Global Regulatory TA Head for development of appropriate regional 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 to VP level and representing GSK with at least the local regulatory agency. The role will work closely with local / regional commercial teams to secure best possible labelling commensurate with the available data. Will also lead interactions with local / regional regulatory authorities.

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

Key Responsibilities:
  • Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to 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.
  • Advocate persuasively approaches to senior leaders in GSK and in Health Authorities
  • Provide assessments of potential in license molecules .


Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS degree in a biological or healthcare science.
  • Experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
  • Experience of leading regional development, submission, and approval activities in local region(s). Experience organizing and executing milestone meetings. Experience with clinical trial and licensing requirements in all major countries in the region.
  • Oncology Experience required with the regulatory affairs space.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project. Developing an external network
  • Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Establishes team goals and uses to seek to improve performance, with ability to set challenging but realistic targets.
  • Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions.
  • Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.


Business Skills
  • Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques.
  • Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
  • Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
  • Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.


#LI-GSK

Please visit GSK US Benefits Summary t o 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 special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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 GSK's Transparency Reporting For the Record site.

  • Director, Regulatory Affairs, Specialty

    1 week ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: Mar Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory compliance on a global scale? If so, this Regulatory Affairs Management Director role could be an exciting opportunity to explore.As Director, Regulatory Affairs-Specialty, you...

  • Senior Manager, CMC Facilities Regulatory Affairs

    1 month ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Maryland - Rockville, Cambridge Binney Street, Durham Blackwell Street, USA - Pennsylvania - Upper ProvidencePosted Date: May 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. R&D is committed to discovering and delivering transformational vaccines and...

  • Director, Regulatory Affairs CMC Small Molecule, Mature Products

    1 month ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - North Carolina - Research Triangle Park, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: May Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the...

  • Head, Regulatory Affairs

    11 hours ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: UK - London, GSK HQ, Stevenage, USA - North Carolina - Durham, USA - Pennsylvania - Upper ProvidencePosted Date: Jul 9 2024Job Purpose: Accountable for CMC (Chemistry, Manufacturing and Controls) Regulatory activities for GSK's Small Molecule development products, including in-licensed assets through to Early Lifecycle and transition of CMC...

  • Internal Medicine Operational Excellence Director

    1 month ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    ROLE SUMMARYThe Internal Medicine Operational Excellence Director role is an integral member of the Global & US Medical Affairs Teams, and the Operational Excellence & Change Management Team. The Internal Medicine Operational Excellence Director leads the development and implementation of key assigned Global / US category-led initiatives that have an impact...

  • Senior Director, Oncology Global Pricing and Market Access

    2 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - London - New Oxford Street, USA - Pennsylvania - PhiladelphiaPosted Date: Jun Senior Director, Oncology Global Pricing and Market Access Location: Philadelphia, PA, UK (London) & Zug (Switzerland)Global Pricing and Market Access (GPMA) are key to maximizing the value of our products...

  • Director, Digital Communications

    6 days ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    Role Summary:The Director, Oncology Digital Communicationswill plan and deliver an end-to-end digital channel content strategy across Pfizer Oncology to optimize the engagement and reach of content directed at target audiences. This person in this role will lead external positioning strategy and execution for Oncology on digital channels including and our...

  • Associate Director, Oncology GRA

    1 week ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - PhiladelphiaPosted Date: Jul 2 2024Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a...

  • Medical Director, GI Malignancies

    2 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, Philadelphia Walnut Street, USA - North Carolina - DurhamPosted Date: Jun Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you The US Medical Director, Gastrointestinal...

  • Associate Director/Director, Quantitative Systems Pharmacology

    3 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    GlaxoSmithKline LLC Associate Director/Director, Quantitative Systems Pharmacology Collegeville , Pennsylvania Apply Now Reference #: 389362Site Name: UK - Hertfordshire - Stevenage, Cambridge MA, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper ProvidencePosted Date: Mar 4 2024Associate Director/Director, Quantitative...

  • Director, US/Global Analytics Project Management

    1 month ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    ROLE SUMMARYImagine what you could do here at Pfizer. Bring passion and dedication to your job and there is no telling what you could accomplish. We are looking for a Director of Analytics Project Management (APM), leading a portfolio of priority initiatives. Reporting to the APM Capabilities Lead, this person will be responsible for leading the Agile...

  • Clinical Development Director

    3 weeks ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Apr Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this Clinical Development Director opportunity could be an ideal opportunity to...

  • Executive Director Precision Medicine Portfolio Planning

    3 days ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, WalthamPosted Date: Jul 5 2024At GSK, we are creating an agile and more competitive Pharma business equipped to win in a dynamic external environment by improving our pipeline and performance. We will prioritize taking rapid, decisive action to focus the portfolio and accelerate timelines across four core...

  • Director, AIDA R&D, Data Solutions Engineer

    3 weeks ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    Role SummaryClinical Development Data Solutions and Engineering, a Pfizer Digital organization part of the AI Data and Analytics team, is responsible for the development and management of all data and analytics tools and platforms for Clinical Development across Pfizer's portfolio. One of the team's top priorities is the advancement of AI/ML enabled...

  • Director, AIDA R&D, Data Solutions Engineer

    1 month ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    Role SummaryClinical Development Data Solutions and Engineering, a Pfizer Digital organization part of the AI Data and Analytics team, is responsible for the development and management of all data and analytics tools and platforms for Clinical Development across Pfizer's portfolio. One of the team's top priorities is the advancement of AI/ML enabled...

  • Director, Insight Strategy, and Execution

    3 weeks ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    Director, Insight Strategy, and Execution page is loaded Director, Insight Strategy, and Execution Apply locations United States - Pennsylvania - Collegeville United States - New York - New York City time type Full time posted on Posted 4 Days Ago job requisition id Pfizer is seeking a Director of Insights Strategy & Execution (ISE) that will lead strategic...

  • Vice President- Vaccine Clinical Research

    13 hours ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    ROLE SUMMARY The primary purpose of the job is to oversee and ensure that vaccine clinical research and development program(s) are planned and implemented to meet company objectives.The Franchise Head applies extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across a...

  • Director, Epidemiology

    1 month ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, UK - London - BrentfordPosted Date: May Would you like to be part of GSK's Epidemiology Department, with an opportunity to drive Epidemiology strategy and studies across the spectrum of drug development? If so, this is an excellent opportunity to...

  • Senior Director, Vaccine Clinical Research

    2 weeks ago

    Collegeville, Pennsylvania, United States Pfizer Full time

    ROLE SUMMARYThe clinician medical monitor should be able to function independently and have direct experience with all the steps in designing and delivering results of clinical trials by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical...

  • Senior Director, Pipeline Project Management, Oncology

    1 month ago

    Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - Upper Providence, StevenagePosted Date: May GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Our goal is to be one of the most innovative, best performing, and trusted healthcare companies.In GSK, the Pipeline...