Regulatory Affairs Manager

This is a fully remote position, open to applicants in Poland.

📋 Description

• Drive regulatory success within the Polish market while spearheading high-value client initiatives across a broad healthcare spectrum.

• Assist in regulatory strategy, submissions, lifecycle management, and interactions with authorities for products governed in Poland.

• Oversee regulatory activities and client projects tailored to Polish market standards.

• Safeguard and uphold marketing authorizations, directing submission and lifecycle management efforts.

• Engage with health authorities and provide guidance on regulatory strategies.

• Coordinate project execution aligning with established timelines and KPIs.

• Prepare, review, and organize regulatory documentation for submissions, renewals, variations, and lifecycle maintenance tasks.

• Facilitate scientific advice procedures and represent clients during interactions with health authorities in Poland.

• Monitor and apply regulatory intelligence, disseminating relevant updates and insights throughout the team.

• Adhere to, sustain, and enhance internal regulatory and operational processes including the development of SOPs and working instructions, as necessary.

• Review change controls, deviations, quality events, and associated records to assess regulatory impacts and support compliant resolutions.

⛳️ Requirements

• A bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related discipline, or equivalent experience is required.

• Over 3 years of experience in regulatory affairs concerning marketing authorizations in Poland.

• Demonstrated experience in regulatory affairs or a similar field necessitating strong technical and practical regulatory expertise.

• Significant hands-on experience managing new submissions and lifecycle management activities for medicinal products in Poland.

• Additional experience in regulatory activities within the EU is advantageous.

• Experience with related product categories such as medical devices, cosmetics, food supplements, or herbal products is beneficial.

• In-depth knowledge of Polish regulatory requirements and procedures.

• Capability to implement tactical goals across customer and internal projects.

• Proven ability to juggle multiple priorities, identify risks, and take proactive measures to keep projects on schedule.

• Structured, analytical, systematic, and independent work approach.

• Strong problem-solving skills characterized by a pragmatic and service-oriented mindset.

• Excellent relationship management abilities across both daily operational contacts and client leadership.

• Outstanding written and verbal communication skills, including the capability to present issues and recommendations clearly to decision-makers.

• Robust presentation skills and a confident, professional demeanor.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned with local market practices.

• The eligibility and effective date may differ for certain benefits and for team members covered under collective bargaining agreements.