Consumer Healthcare, Senior Manager of Regulatory Affairs
Location:
Warren , New Jersey
Posted:
November 22, 2017
Reference:
WD144456
Basic qualifications:
Bachelor's Degree in Related Field.
At least 8 years of experience in Regulatory Affairs within the Life Sciences industry.
Significant experience interpreting and applying the OTC drug monograph, Investigational New Drug Application (IND) and New Drug Application (NDA) processes to ensure timely and compliant product launches.
Experience preparing electronic Common Technical Document (eCTD) and ensuring regulatory compliance with OTC labels and promotional materials.
Strong understanding of US Regulatory process ensuring FDA compliance
Ability to interpret, understand and relay government regulations

Preferred qualifications:
Master's Degree in Regulatory Affairs or Related.
Experience in Regulatory Affairs for a Consumer Healthcare organization.
10+ years of Regulatory Affairs Experience
Delivery of training on key regulatory legislation, systems, processes and/or projects.
Project budget responsibility.
Excellent communication skills both verbally and written.

Details:
Company Overview:
GSK Consumer Healthcare is one of the world's largest consumer healthcare companies. Our purpose is to help more people around the world to do more, feel better and live longer with everyday healthcare products. We have a heritage that goes back over 160 years. We own some of the world's best loved healthcare brands, including Sensodyne®, Theraflu®, Excedrin®, Nicorette®, Flonase® and TUMS®.

Our goal is to build a global, growing business we call a Fast Moving Consumer Healthcare company, dedicated to everyday healthcare with all of the scientific expertise and quality guarantees that demands, working at the speed and with the genuine consumer understanding the modern world expects.

Key Job Responsibilities:
Interacts with regulatory agency personnel in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters.
Contributes to the development of global and/or local regulatory strategies and identifies gaps that may impact implementation within their area of responsibility and translates regional/global regulatory strategies into executable plans for the department/area.
Manages functional activities to ensure short and long term objectives are achieved in a proactive, cost and time efficient way.
Understands the regulatory landscape across an assigned area of business. Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest and participates in influencing activities for regulatory reform in specific areas.
Provides risk assessments balancing business needs and the needs of consumers or the risks of being challenged by NGO'S, authorities or competitors.
Partner with other critical functions to execute plans to address crises and other sensitive issues.
Manages compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
Responsible for preparing, submitting and signing off on Regulatory submissions for assigned projects.
Develops, translates, reviews (if relevant) and approves artwork and promotional copy to ensure regulatory compliance for submissions.
Establishes project success criteria and monitors activities.
Provides executive summaries and status updates on product/project activities to Senior Management and key internal/external stakeholders.
Contributes to the development of regulatory strategies and identifies gaps that may impact implementation.
Represents GSK and provides regulatory advice at e.g. joint company/trade association initiatives, regulatory agency meetings etc. (as appropriate).
Oversees or initiates development of best practices for Regulatory Affairs processes and displays working knowledge of process optimization during implementation.
Provides direction and offers solutions to complex problems in which data analysis requires an evaluation of intangible variables.
Ensures quality and compliance in all actions

*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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