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Director, US Regulatory Affairs - Switch

Employer
GSK
Location
Warren, New Jersey
Salary
Competitive
Closing date
Jun 29, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Job Type
President/CEO/Director/VP
Organization Type
Pharma
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This position serves as a regulatory leader within the Switch Team. As a trusted advisor to cross-functional partners, this individual will lead team to deliver well-constructed and considered regulatory strategies that meet regulatory requirements, business objectives and consumer needs. This is a strategic role with considerable responsibility. The individual must build strong relationships with all stakeholders, internal and external, to guide organizational decision-making and influence positive outcomes.

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

Growth:
  • Advise the business on the regulatory aspects of Switch. Must be abreast of healthcare trends and how they may impact the regulatory environment and our business.
  • Lead Regulatory assessments of new opportunities, assessing feasibility based on a comprehensive evaluation of the science and the issues likely to be raised by the Switch.
  • Create regulatory strategies that guide the best delivery of Switch innovation.
  • Use internal and external networks to ensure regulatory strategies are robust and keep pace with the evolving regulatory environment.
  • Guide the development and testing of product labeling to achieve regulatory approval and support commercial success.
  • Partner with cross-functional team members to develop competitive advertising and promotion, ensuring risks are appropriately addressed and communicated.
  • Advise on the design of investigational research (labeling, CMC, Clinical) to efficiently and effectively progress development programs at pace.
  • Proactively identify potential regulatory risks and mitigation strategies to enable program acceleration and smart risk-taking.
  • Direct the strategy and execution of INDs and NDAs to achieve on-time submission and first cycle approval.
  • Deliver clear, compelling, and well-constructed regulatory communications for internal and external audiences
  • Lead interactions (meetings, teleconferences) with regulatory authorities to seek guidance, resolve issues and expedite approval of pending applications.
  • Lead and develop regulatory team members to have strong regulatory capabilities and become future leaders.


External Engagement:
  • Cultivate external network of key advisors to rapidly leverage expertise when needed.
  • Build strong relationships with the healthcare community, regulators, trade associations and others who are influential in the Self Care/Switch arena to identify regulatory threats and opportunities.
  • Engage in appropriate activities to help shape policy and the regulatory environment.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Life science/Pharmaceutically-related science
  • 10-12 years Regulatory Affairs experience
  • Minimum of 5 years' experience in Consumer Healthcare/OTCs
  • Direct knowledge and practical experience with Rx to OTC switch, INDs and NDAs


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP
  • Ability to understand the business impact of regulatory decisions
  • Strong verbal and written skills
  • Highly skilled in scientific interpretation/evaluation/communication of technical information
  • Ability to influence others and effectively interface with internal and external stakeholders at varying levels of seniority
  • Experience working in cross-functional teams and across a matrixed environment
  • Adept at creative problem-solving
  • Demonstrates mental agility to flex between high level strategy and detailed execution
  • Experience with Medical Devices and/or SaMD


Why Consumer Healthcare?

Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

Diversity, Equity and Inclusion

In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

*LI-GSK

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.

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