Senior Manager, Category Regulatory Affairs-Skin Health
Location:
Warren , New Jersey
Posted:
October 16, 2017
Reference:
WD135154
Basic qualifications:
Bachelor's Degree or equivalent in a pharmaceutical or life science or equivalent regulatory experience
5 years of Regulatory experience in Consumer Health or related industry.
Awareness of regulatory processes in different geographic regions

Preferred qualifications:
5+ years of Regulatory Experience in CH or related industry.
Experience with medicinal product regulations
US/EU Regulatory experience.
Significant experience with products related to the skin health category portfolio
Proven record of developing regulatory strategies for complex projects and of resolving issues.
Experience of working flexibly across a portfolio of products
Demonstrated Commercial Awareness and ability to act as a Business Partner
Demonstrated ability to positively impact the business

Details:
Company Overview:
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better, live longer.
We are focused on the research and development of innovative pharmaceutical medicines, vaccines and consumer healthcare products.
The GSK Consumer Healthcare business has a portfolio of some of the world's most trusted and well loved brands. Our brands are underpinned by science-based innovation and include Panadol, Voltaren, Horlicks and Sensodyne and have been developed to meet the healthcare needs of consumers worldwide.

Job Purpose
The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. In this role the individual will build a network of collaborative relationships within the sub-category and LOCs and ensure all regulatory requirements are met for both new innovation and existing products according to GSK Values.
In this role an individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission.
The role may require the individual to provide specialist regulatory advice across the Category and Function.

Key Job Functions:
Acts as a Business Partner and provides regulatory advice across sub-Category/significant portfolio on all aspects of drug/cosmetic/devices development and regulatory requirements, both current and future.
Provides regulatory direction for a sub-category/significant portfolio of products. Develops novel regulatory strategies and influences approaches in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
Communicates influences and negotiates effectively with cross-functional internal and external groups at all levels.
May lead an efficient and well motivated small team; including effective people development.

*GSK-LI

Contact information:

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A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

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