GSK

Regulatory Affairs Systems & Metrics Manager

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
September 18 2020
Ref
263943
Organization Type
Pharma
Job Type
Manager
Regulatory Affairs Systems & Metrics Manager

The purpose of the Regulatory Affairs Systems & Metrics Manager role is to provide leadership and supervision of Global Regulatory Systems and Metrics processes, including implementation, maintenance and validation of regulatory systems and regulatory Metrics / KPIs within the Consumer Healthcare Global Regulatory Affairs.

The Regulatory Affairs Systems & Metrics Manager role is responsible for the regulatory systems and processes for regulatory information management / tracking (RIMS) and electronic document management (EDMS) for regulatory documentation, including archival of regulatory submissions. This role is responsible for the generation and dissemination of the regulatory reports, metrics and key performance / quality indicators (KPI's/KQI's).

This role will work closely with regional and key local regulatory GSK Consumer Health (CH) teams, and key external/internal functions to ensure GSK CH systems provide regulatory information to external compliance databases (e.g. EU Art 57) and other PV systems.

Responsibilities:

This role will proactively evaluate systems and processes and recommend improvement activities to enhance the speed of innovation delivery and deliver efficient compliance (incl. internal vs external delivery models).
  • Oversees the operational delivery of Systems & Metrics Team, responsible for:
    • Capture and management of registration information for all GSKCH products, in the Regulatory Information Management System, including user support and training on the systems and processes.
    • Reporting of regulatory product and registration information in support of GSK CH Global regulatory, GSK and external compliance obligations.
    • Driving high-levels of registration data compliance in partnership with central and local regulatory colleagues
    • Maintenance and enhancement of the RIM systems to ensure optimal support to internal and external needs.
    • Responsible for the identification, approval and evolution of compliant, efficient and relevant regulatory services and systems, including system upgrades; best-practice process improvements; and regulatory intelligence.
    • Develops good working relationships with internal and external partners, to ensure effective communication, influencing and delivery of operational and strategic objectives.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Life Science, Computer Science or other related discipline
  • 5-10 years' experience in regulatory operations (or similar) role
  • Experience and knowledge of the global affiliate requirements for the commercialisation and maintenance of Consumer Health H products in the market.
  • Experience and knowledge of consumer regulatory product categories, e.g. medicines, cosmetics, medical devices and foods
  • Experienced in Delivery of quality and compliant services, including regulatory publishing and information management.
  • Demonstrates a working knowledge of the development, commercial manufacture and regulation of the major product classifications.
  • Experience and knowledge about identification, implementation and evolution of compliant, efficient and relevant services and systems.
  • Experience and knowledge of regulatory systems and operations services used for the support, accurate capture and dissemination of regulatory information and activities.
  • Experience and knowledge of current external regulatory information-related guidance and evolving vision.
  • Builds relationships within company, trade associations and regulatory authorities to influence the regulatory environment in-line with company strategies.
  • Has an awareness of the R&D functions and processes that interface with the regulatory function.
  • Implements global regulatory operations processes and systems projects.
  • Builds connections with stakeholders and drives enterprise and best-practice thinking.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Ability to communicate effectively with peers and business stakeholders at varying levels of management
  • Relationship Building skills across different functional and technical groups


Why GSK?

Our values and expectationsare 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:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.


*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.

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