We are looking for a

Regulatory Affairs Manager

for 2 years defined period, 0,75 FTE position

Position summary:

The positon holder will be responsible for full scope of Regulatory Affairs tasks in his/her therapeutical area, and support business activities with providing professional advise for the different other functions.

Responsibilities:

Managing Regulatory Processes

• EU Regulatory Processes (Centralised Procedures): Keeping contact with global headquarter and health authorities, providing country specific information to them, furthermore preparing and coordination of translations of documentations in each phase of the centralised procedures.
• Preparing new marketing authorization application submissions (MAA) in the mutual recognition, decentralized and national procedures. Finalising the product information in the national phase with the local health authority.
• Product Life Cycle Management: Maintenance and compliance of registration data of the registered products (variations, safety updates, renewals).
• Supporting Artwork development processes: Active contribution to the registered products’ artwork projects with development, review and/or approval responsibility.

Operational Activities & Data Archiving

• Professional archiving of the registration documentations belonging to his/her therapeutic area in compliance with the company procedures.
• Actively contributes to the regulatory planning

Business support activities

• Acting as regulatory consultant in related questions belonging to his/her competence.
• Providing product information in his/her therapeutical area to Medical, Sales and Marketing functions.
• Giving advice in promotional affairs.
• Liaisoning with Medical, Market Access, Quality Assurance, Business Unit/Marketing, Supply Chain, Logistics and Finance Department

Strategy and Planning

• Supporting product launch strategies
• Involvement in local regulatory budget estimates (fees for registration, cost of other regulatory activities).

Regulatory Intelligence

Knowledge of current national and EU regulations ensuring the highest professional level in his/her fields of responsibility.

Company procedures

Ensuring compliance to all relevant global or local policies and procedures with a special focus on Regulatory related processes.

Requirements:

• University degree in Pharmacy, Medical, Biology or Natural Sciences
• 4-5 years regulatory experience in pharmaceutical industry
• Experience with national regulatory submissions and with mutual recognition/decentralized procedures
• Proficiency in the Quality Review Document preparation.
• Fluent English both in written and spoken language
• Computer literacy (Microsoft Office, Outlook)
• Driving licence “B” and driving practice

Personal profile:

• Analytical skills and able to synthetize
• Open to challenges
• Result orientation
• Precise and reliable
• Excellent communication and problem solving skills
• Able to work independently and also in team
• Open to learn

What we offer:

• Competitive salary
• Cafeteria flexible benefits
• Company car
• Working in team
• Career Development

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.