Regulatory Affairs & PV Manager

Job description

Stellenbeschreibung

Job Purpose
Manage and coordinate the different local health registration activities to obtain and maintain marketing authorization of medical devices and medicinal products including clinical study authorizations within Alpine Cluster and acts as the deputy to the Head of RA Alpine Cluster.

Main Responsibilities

Health registration activities
• Monitor operational progression of pre-marketing authorization activities at country level through contact with the Austrian & Swiss regulatory agencies or committees, as required.
• Obtain approval for the marketing of Alcon medicinal products & medical devices as well as for clinical studies, and maintain the portfolio within Alpine Cluster
• Establish/update product labelling for medicinal products & medical devices
• Collaborate with corporate and regional Regulatory Affairs, and meet their deadlines in regards to registration activities (e.g., providing input to RIARs)
• Strategic communication with the Austrian & Swiss regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions
• Ensure all documents submitted to Austrian & Swiss regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review
• Submits renewals, CMC and safety variations for medicinal products according to timelines to the local health authorities in Austria & Switzerland
• Maintain records of regulatory submissions and communications with the relevant Austrian regulatory agencies.
• Monitor and provide regulatory intelligence on new medicinal product & medical device legislation (with the authorities), guidance and policy proposals impacting Alcon’s products or processes. Monitor and provide regulatory intelligence on the Austrian healthcare system, competitive products and companies.
• Establish and maintain excellent working relationships with Austrian & Swiss authorities and associations; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.
• Ensure Alcon is adequately represented in relevant regulatory advocacy groups, and the company position is considered as health authorities propose new regulations.

Compliance Management
• Work with commercial colleagues to develop promotional strategies, and provide regulatory review and approval for promotional materials according to local law and Alcon Compliance policies and tools.

Medical Information
• In the absence of local Medical Affairs, receive and forward queries for medical information to the responsible global group, and respond accordingly to the enquirer in accordance with company standards and local regulations; reconcile cases with Vigilance/GDD department.
• In the absence of local Medical Affairs, review promotional materials from a medical perspective (in strong collaboration with regional Medical Affairs)

Market access/Pricing& Reimbursement
• Maintains the information in the Warenverzeichnis

General
• Ensure compliance with ISO 13485, Good Manufacturing and Distribution Practice (GMP/GDP); apply national regulations and guidelines and company policies, and ensure high ethical conduct.
• Vigilance Clause: Jobholder is obligated to report any complaint (e.g. Adverse Event or Quality complaint) within 24 h from the receipt to the Vigilance department in accordance to the valid local SOPs
Positionsbezeichnung

Regulatory Affairs & PV Manager

Desired profile

Mindestanforderungen

• University degree in a life science discipline
• Fluent in German and English, both spoken and written (required)
• 2-5 years in Regulatory Affairs or similar functions
• local and European drug and medical device regulations
• scientific and pharmaceutical-technical judgement
• managerial and problem solving capabilities
• excellent communication and negotiation skills
Art der Stelle

Vollzeit
Land

Schweiz
Standort

Rotkreuz
Funktionsbereich

Research & Development
Division

ALCON
Geschäftseinheit

COMMERCIAL EMEA AL
Anstellungsverhältnis

Unbefristet
Unternehmen/Rechtsträger

ALCON AUSTRIA