Regulatory Affairs Manager (Pharma)

Regulatory Affairs Manager (Pharma)

B2B contract via Harvey NashRemote in Poland (visits to Warsaw office from time to time)Duration: 12 months (+extension probable)End-client : PharmaTech company

Responsibilities:

• Contribute to the development and execution of global regulatory strategies (pharma products lifecycle - clinical development, registration, and post-approval activities), Provide regulatory leadership for lower-complexity programs, Provide strategic regulatory input to key program deliverables

• Lead planning, preparation, and submission of clinical trial applications and other documents

• Assure regulatory excellence & compliance (act as regulatory SME)

• Effective identification and mitigation of regulatory risks and opportunities

• Successful execution of regulatory strategies resulting in timely submissions and approvals

• High quality interactions with health authorities and internal stakeholders

• Full compliance with regulatory and quality requirements

Requirements:

• Higher education – preferably related to Regulatory Affairs, Pharma or Medicine

• 4+ years of experience in pharmaceutical regulatory affairs and development

• Exposure to one or more major regulatory regions (e.g., EU, US)

• Experience working in cross-functional, matrixed team environments

• Fluent in English

• Allowed to work on B2B basis in Poland