Regulatory Affairs Manager (EUROAPI Prostaglandins - Small Molecules)

Regulatory Affairs Manager (EUROAPI Prostaglandins - Small Molecules)

Sanofi

Budapest, Hungary

JOB PURPOSE:

Within EuroAPI manufacturing site of Ujpest involved in third party supply for Small Molecules & Prostaglandins API, the purpose of the Regulatory Affairs Manager role is to ensure Regulatory Affairs (RA) coordination related to sales activities worldwide.

KEY ACCOUNTABILITIES:

Regulatory Expert acting between the Customers and the Manufacturing site:

  • Within the EUROAPI Ujpest site and corresponding portfolio (Prostaglandins and Small Molecules), manage and achieve answers relative to non-standard/specific RA requests from customers;
    • Develop regulatory strategies, provide regulatory guidance & expertise and keep oversight of the EuroAPI projects, from development to maintenance of marketed APIs;
    • Keep track and planning of actions on chemistry dossiers and technical packages for each customer with the assigned manufacturing site(s). Follow-up of the regulatory actions from customers and informs Regulatory Site Officer (RSO) on external customer’s regulatory expectations;
    • Define priorities EuroAPI projects through the Regulatory Long Range Plan, in full alignment with Regulatory Site Officers (RSOs) and the business priorities;
    • Collect and consolidate RA feedbacks from the EuroAPI zones and customers into projects products strategies;
    • Guarantee the adequate regulatory assessment of Change requests issued by the RSOs and the follow-up of the decisions, information to customers, keeping track through the customer portal/QA RA database.
  • Lead the relationships between the manufacturing site, EuroAPI Zones, EuroAPI sales organization, and the customers:
    • Ensures product-specific RA information is shared in timely manner with relevant counterparts.
  • Contribute to the CMC writing activities for the Prostaglandin portfolio, in cooperation with Regulatory Site Officers:
    • Take a supportive and operational role in CMC writing for the Prostaglandin documentation portfolio.
  • Keep record of key regulatory processes and reports corresponding KPIs for Customer Excellence policy;
  • Could act as a back-up of a EuroAPI Sales Quality Manager acting for same product portfolio.

REQUIREMENTS:

  • Degree in Pharmacy, Chemistry/Biochemistry;
  • Min. 6 years experience in the pharmaceutical industry with GMP requirements, International Regulatory Affairs & Regulatory Compliance;
  • Good management experience with demonstrated leadership skills;
  • Excellent communication skills, Fluent English & advanced Hungarian language knowledge;
  • Problem solving/conflict resolution skills, good conviction strengths;
  • Solid program and project management skills, strong team player;
  • Flexible, agile & willing/available to travel;
  • Good knowledge of MS Office tools (Outlook, PowerPoint, Excel, Windows) and Regulatory Document Management System.

NICE TO HAVE:

  • Strong background in Active Ingredient manufacturing.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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