Regulatory Affairs Associate

仕事内容

Site Name: Belgium-Wavre, Brondby, Solna, Netherlands - Amersfoort
Posted Date: Feb 16 2021

This opportunity is for a 1 year contract initially.

As Regulatory Affairs Associate you are responsible for Regulatory Affairs in defined portfolios or activity streams within your markets/areas.

This Includes That As Regulatory Affairs Associate

• You ensure products within scope (incl. medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans
  
• You ensure products are maintained and meet internal and external compliance requirements
  
• You are a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, e.g., marketing/sales within local commercial business, supply chain and quality etc.
  
• You engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK Consumer Healthcare with local regulators, trade associations and other key external regulatory bodies.
  
• You work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges
  
• you provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
  

Your Responsibilities

• You manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
  
• You analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs
  
• You actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance
  
• You build relationships with key stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK Consumer Healthcare policies and strategies
  
• You manage compliance within defined portfolio/activity streams in line with GSK Consumer Healthcare expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements, artworks as well as local MoH regulations)
  
• You work together with other functions (eg, marketing, supply chain) to deliver NPD and value engineering projects
  
• You support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
• You proactively manage impact of regulatory changes within defined scope of responsibility on the business
  
• You maintain required regulatory compliance databases, systems and processes
  
• You maintain high level of knowledge on the science of products within defined portfolio
  
• You guarantee medical device registration to the National Health Authority databases.
  
• You guarantee cosmetic registration in the CPNP database in case of locally managed Cosmetics.
  
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Higher degree or equivalent with experience
• Minimum 1-year experience in a similar function or EU regulatory affairs environment.
• Fluent in English.
  
  

Preferred Qualifications

If you have the following characteristics it would be a plus:

• Eager learner
• Pro-active, can-do mentality
• Team player

Li-GSK

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 in a culture of Innovation, Performance and Trust.

GSK Consumer Healthcare – Our Consumer Healthcare business develops and markets consumer preferred and expert recommended brands in the Oral Health, Pain Relief, Respiratory, Nutrition/Gastro-intestinal and Skin Health categories.

For further information, please visit www.gsk.com.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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