This job has expired

Director, Global Regulatory Affairs

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Jun 24, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Job Type
President/CEO/Director/VP
Organization Type
Pharma
You need to sign in or create an account to save a job.
The Director, Global Regulatory Affairs ensures the development of appropriate regional and global regulatory strategies and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal is achieved both as a component of an overall regional or global regulatory approach and ensures 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:
  • Ensuring the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
  • Implementation of the regional strategy(ies) 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 lifecycle


Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals (must-have):
  • Bachelor Degree
  • Experience in all phases of the drug development process in regulatory affairs
  • Experience in leading regional development, submission and approval activities in local region(s)
  • Experience in organizing and executing successful milestone meetings with one or more Health Authority
  • Knowledge of clinical trial and licensing requirements in the US & Globally
  • Knowledge of Drug Development or Product Development
  • External network experience


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Advanced Degree in Biological OR Health Science
  • 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 teamaccountable 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 Health Authorities and ensuring compliance with regulations 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 make 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.
  • 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 provide coaching, mentoring and performance feedback to regulatory colleagues.


Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

*LI-GSK

*This is a job description to aide in the job posting, but does not include all job evaluation details.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert