RA Head

Alcon

Warsaw, Poland

Job Description

Person in this role will be responsible for new product registration and maintenance of existing product licenses within the country. Interact with Global Regulatory Affairs groups, Regional Regulatory Affairs team, Region Clinical and Medical Affairs team, GDD-RA, Country/Cluster business leaders. Also acts as a member of the Country Management team.

  • Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products in the country, aligned with Global Regulatory and Region and Country business strategies and plans.
  • Responsible for establishing and management of regulatory staff in the country and driving performance as measured by expeditious development of plans, regulatory submissions and approvals in the country.
  • Monitor operational progression of pre-marketing authorization activities at country level through contact with country regulatory agencies or committees, as required.
  • Strategic communication with the country regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions.
  • Ensures all documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review.
  • Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies.
  • Work with commercial colleagues to develop promotional strategies and provide regulatory review for promotional materials.
  • Monitor and provide regulatory intelligence on new medical device legislation, guidance and policy proposals impacting Alcon’s products or processes. Provide regulatory intelligence on competitive products and companies.
  • Accountable for ensuring Alcon is adequately represented in relevant regulatory advocacy groups, to ensure the company position is considered as new regulations are proposed by health authorities.

Qualifications

  • Minimum requirements Master’s degree in a related field is required. Fluent English At least 7 to 10 years in Regulatory Affairs, with significant depth of experience within the medical device industry.
  • At least 2 years of experience leading people and organizations A track record of successful execution of regulatory submissions and approvals for medical devices.

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© EuroJobsites 2019

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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