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New job- FMCG Regulatory Assistant Manager

  • £50,000-55,000
  • Permanent
  • Central London
  • Ref:20230

Regulatory Assistant Manager

The Skills You'll Need: Regulatory Affairs, healthcare, pharmaceutical, medical, MDR
Your New Salary: £50,000-55,000
Location: London
Who You'll Be Working for: FMCG company

What You'll be Doing Each Day:

Responsible for support of organizing Regulatory Affairs of consumer products.
In charge of medium to long-term Regulatory operations including local systems improvements, local staff training and future business expansion.

• Improve the regulatory management system with Regulatory Manager.
• Develop and implement a Regulatory Program including policies, procedures (SOPs), ensuring that all governmental regulatory regulations including MHRA requirements for company products are achieved.
• Prepare, record, and manage documents necessary to establish the system of Regulatory Affairs in order that company will have been selling regulatory products sustainably.
• SOPs of which include; The rules to record all information related with Regulatory Affairs/ The rules to maintain our certifications/ The guidelines to address new product developments
• Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
• In-charge with the timely approval and renewal of product licenses, company certificates, through working with Regulatory officials, Notified Body(s) and regulatory consultant(s).
• Deal with audits which are implemented by Notified Body(s) and consumers, which includes supporting our own factory(s) when audited in order to maintain our certificates.
• Review technical dossier of products and prepare additional documents where necessary.
• Handle post-marketing activities and yearly reporting requirements of company and product licences.
• Analyse relevant regulatory trends - Keep updated with regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
• Maintain a current awareness of the regulatory requirements for the general legislation and guidelines (for instance REACH and Environmental regulations including recycling etc...) in EU.

The Skills You'll Need to Succeed:

• Bachelor’s Degree preferred
• Experiences in Regulatory Affairs or Certifications as Auditor of Notified Body(s) for CE certificated products
• MDR transition’s experiences desirable
• Strong computer skills including Microsoft Office and Databases.
• Communication skills-verbal and written of Chinese or Japanese
• Must be able to go on business travel

Job status: Permanent
Start date: TBC
Core hours: 9:00-17:00

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