Current jobs related to Director, Regulatory Affairs, Specialty - Collegeville, Pennsylvania - GlaxoSmithKline
-
Regulatory Affairs Director
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob PurposeAs a key member of the GlaxoSmithKline team, the successful candidate will be responsible for developing and executing regional regulatory strategies that align with the company's Medicines Development Strategy. This will involve working closely with cross-functional teams to ensure compliance with internal processes and regional regulatory...
-
Director, Global Regulatory Affairs, Vaccines
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at GlaxoSmithKline as a Director, Global Regulatory Affairs, Vaccines. This role will be responsible for ensuring the development and execution of regulatory strategies for assigned US assets, across all stages of the product life cycle.Key...
-
Director of Regulatory Policy and Advocacy
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly experienced and motivated Director of Regulatory Policy and Advocacy to join our dynamic team at GlaxoSmithKline. This role will be pivotal in shaping and influencing regulatory policies related to Chemistry, Manufacturing, and Controls (CMC) on a global scale, with a particular focus on supporting our growing digital,...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Executive Director to lead our Diagnostics Precision Medicine efforts at GlaxoSmithKline. As a key member of our R&D team, you will be responsible for driving scientific innovation and excellence in diagnostics and precision medicine.Key ResponsibilitiesLead the development and implementation of...
-
Medical Director Oncology Clinical Development
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled Medical Director to join our Oncology Clinical Development team at GlaxoSmithKline. As a key member of our team, you will be responsible for leading clinical research activities and advancing the development of our clinical portfolio.Key ResponsibilitiesCollaborate with cross-functional teams to develop and...
-
Medical Director for Respiratory Assets
2 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled Medical Director to join our team at GlaxoSmithKline. As a key member of our Medical Matrix Team, you will be responsible for developing and executing medical strategies for our respiratory assets in the US market.Key ResponsibilitiesDevelop and implement US medical strategies aligned with commercial asset...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled Medical Director to lead our Respiratory Therapeutic Area in the US. As a key member of our Medical Matrix Team, you will be responsible for developing and executing medical strategies to drive business growth and improve patient outcomes.Key ResponsibilitiesDevelop and Execute Medical Strategy: Collaborate with...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeJob SummaryWe are seeking a highly skilled and experienced professional to join our team as an Associate Director/Director, Patient Reported Outcomes Specialist. This role will play a critical part in the development and implementation of patient-centered outcomes strategies across our portfolio.Key ResponsibilitiesDevelop and Execute Patient-Centered...
-
General Counsel, Healthcare
3 weeks ago
Collegeville, Pennsylvania, United States Pfizer Full timeThe Global Product Counsel (GPC) will serve as counsel for prescription product(s) across one or more businesses within Pfizer's Primary Care, Specialty Care, and/or Oncology. This GPC will provide legal guidance and counsel to commercial, medical, and corporate teams, including Business Development, Regulatory Affairs, and Compliance. The GPC will work...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timePosition Overview:The Senior Vice President of Clinical Research Initiatives will spearhead the strategic development, innovation, execution, and oversight of all interventional clinical trials within the medical affairs division. This includes the formulation and implementation of a comprehensive portfolio of medical affairs-sponsored Phase IV studies.This...
-
Medical Governance Director
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Medical Governance Director to join our team at GlaxoSmithKline. As a key member of our organization, you will play a critical role in ensuring the effective management and implementation of medical governance processes across our business.Key ResponsibilitiesMedical Governance Oversight: Provide...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Bioanalysis and Biomarkers Platforms team at GlaxoSmithKline. As a key member of our team, you will be responsible for leading the development and implementation of bioanalytical strategies for our pharmaceutical products.Key ResponsibilitiesLead Bioanalytical Projects: Oversee the...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director to join our DMPK Development Support team at GlaxoSmithKline. As a key member of our team, you will be responsible for providing DMPK input into project strategy and data interpretation for small molecule development stage projects.Key Responsibilities:Develop and implement DMPK...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking an experienced Associate Director to join our Bioanalysis and Biomarkers Platforms department within Precision Medicine at GlaxoSmithKline. As a key member of our team, you will be responsible for managing the full life cycle of our studies, including method development, assay transfer/validation, and working closely with...
-
Director of Clinical Pharmacology and Modeling
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly motivated and experienced Director-level quantitative clinical pharmacologist to join our team at GlaxoSmithKline, supporting the oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department.Key ResponsibilitiesContribute to the design of efficient clinical development...
-
Clinical Development Director
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled Clinical Development Director to lead our efforts in the respiratory therapeutic area. As a key member of our team, you will be responsible for driving the clinical development of novel assets to treat pulmonary diseases.Key ResponsibilitiesContribute to the development of clinical development plans (CDPs) for...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Executive Director to lead our Diagnostics and Precision Medicine efforts at GlaxoSmithKline. As a key member of our R&D team, you will be responsible for driving scientific innovation and excellence in diagnostics and precision medicine.Key ResponsibilitiesLead the development and implementation...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Executive Director to lead our Diagnostics and Precision Medicine efforts at GlaxoSmithKline. As a key member of our R&D team, you will be responsible for driving scientific innovation and excellence in diagnostics and precision medicine.Key ResponsibilitiesLead the development and implementation...
-
Director of Human Resources
2 days ago
Collegeville, Pennsylvania, United States InsideHigherEd Full timeJob SummaryThe Director of Human Resources is a senior leadership role responsible for shaping and executing the strategic vision for human resources at Ursinus College. This individual will lead the strategy for Human Resources, optimize the Human Capital Management System, and ensure the effective implementation of HR policies and initiatives.Key...
-
Director of Financial Planning and Analysis
3 weeks ago
Collegeville, Pennsylvania, United States InsideHigherEd Full time**Job Summary**Ursinus College is seeking a visionary and highly skilled professional to serve as the Director of Budget and Planning within the Finance and Administration division. Reporting directly to the Vice President for Finance and Administration, the Director of Budget and Planning will hold a pivotal role in leading the college's procurement...
Director, Regulatory Affairs, Specialty
3 months ago
Posted 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 will ensure the development of appropriate regulatory strategies and their execution for assigned assets consistent with Medicines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Accountable to GRL (if one assigned) and/or Global Regulatory therapeutic area (TA) Head for development of appropriate regional and/or global regulatory strategies and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned assets, responsible for regional and global regulatory strategies.
In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK at minimum with the local / regional 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. Lead regulatory matrix teams (RMT) as applicable/relevant.
responsibilities include:
- Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally.
- Implementation of the regional strategies in support of the project globally.
- Lead regulatory interactions and the review processes in local region.
- Ensuring appropriate interaction with regional commercial teams in local region.
- Ensuring compliance with regional requirements at all stages of product life from commit to medicine development (C2MD).
- Ideally able to advocate persuasively approaches to senior leaders in GSK and at Health Authorities.
- Capable of providing assessment of potential in-license molecules.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences or pharmacy.
- 5 or more years of regulatory affairs experience in the pharmaceutical industry.
- Experience in all phases of the drug development process, including projects with little or no precedence.
- Experience leading/working on matrix teams involved in developing regulatory strategy, submission and marketing approval activities in local regions and globally.
- Experience organizing and executing successful interactions with Health Authorities.
- Extensive experience with global/regional clinical trial and licensing requirements.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- PhD or Masters' degree in life sciences or pharmacy.
- Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
- 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 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.
- Proven ability to build strong personal networks, and use them to secure appropriate support and outcome for a project. Developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome.
- Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of regulatory 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. 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 weigh benefits and risks before making important decisions.
- 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.
- Ability to interact with regulatory officials and support advocacy initiatives.
- Significant external network at least into other pharmaceutical companies and recognized as an expert broadly or in specific areas of regulatory affairs.
#LI-GSK
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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.
