Currently we are looking for a person for the position: Regulatory Affairs Manager

Place of work: Warsaw

Contract type: Fixed-term contract (18 months)

Tasks and responsibilities

• Lead of the local Regulatory Affairs team.
• Manage registration activities in Poland (NP, DCP and CP procedures).
• Manage allocated products, processes and databases.
• Execute strategy for new submissions in the country and ensure timely and successful submissions.
• Ensure Marketing Authorization maintenance in line with local requirements and global standards (including safety variations, Educational Materials, DHPCs).
• Provide expertise and knowledge of regulatory environment and local Health Authorities.
• Foster close relationships with relevant Authorities and other key stakeholders.
• Provide input to Global RA, Local and Regional RA concepts/strategies/projects.
• Ensure adherence to BI and international compliance rules as well as to local legislation in allocated areas of Regulatory Affairs.
• Contribute to CAPA process as appropriate.
• Perform translation activities.
• Ensure new Regulatory Intelligence is captured via an Impact Assessment and communicated appropriately.
• Constant tracking of all compliance parameters for allocated products and processes (KPIs).
• Support Marketing by preparing short versions of the Summary of Product Characteristics.
• Plan and manage RA budget and spending.

About our future employee

• University scientific degree
• Knowledge of local and international regulatory affairs regulation
• Relevant experience in pharmaceutical industry/CRO is an asset
• Good command of English language
• Organisational and communication skills
• Proactive attitude
• Team- and networker
• Thoroughness
• Strategic thinking
• Ability to judge a case
• Ability to lead & learn

What we offer

In this position, we offer employment based on a fixed-term contract (18 months), great opportunities for professional development, and a competitive bonus system.

Additionally, we offer:

• Remuneration adequate to the level of experience and competence
• Independence in daily activities
• Company car, phone, laptop
• Opportunities for improvement and professional development
• Package of non-salary benefits (medical care, life insurance, Multisport card, My Benefit cafeteria)

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.