Informacje o stanowisku

Opis stanowiska pracy

RA Life Cycle Management CMC Specialist
Warszawa
NR REF.: 1192914

One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals that would contribute to its success by joining the new team.

We are looking for several Senior Regulatory Affairs Specialists who would be responsible for ensuring compliance with regulatory requirements during the lifecycle management of the company39s marketing authorisations. The role involves developing and executing regulatory affairs strategies, preparation of regulatory variation packages as well as authoring the CMC part of the regulatory dossiers.

The position requires a deep understanding of the pharmaceutical manufacturing processes, analytical testing and pharmaceutical legislation and guidelines, coupled with strong communication skills.

The position will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales to ensure variations are managed in due time to ensure uninterrupted supply of our medicines to patients.

Office location: WarsawHybrid model: 3 days office-based, 2 days home-office

Main responsibilities:Regulatory Strategy and Compliance:

• Develop and implement regulatory strategies for variations related to the CMC sections of dossiers to ensure regulatory compliance.
• Stay updated with current regulatory legislation, guidelines and best practices related to CMC.
• Provide regulatory guidance and support to cross-functional project teams.

Document Preparation and Submission:

• Coordinate and compile required documentation, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Review and assess manufacturing changes, analytical methods, and process validations to ensure compliance with regulatory guidelines.
• Prepare and review CMC sections of regulatory dossiers.
• Prepare and review variation packages.
• Manage timelines and ensure timely submission of regulatory variation packages.

Liaison with Regulatory Authorities:

• Act as the primary contact for competent authorities.
• Facilitate communication with regulatory authorities to resolve issues and obtain necessary approvals.
• Prepare responses to regulatory questions.

Daily Operation Tasks:

• Change controls.
• Variations.
• Deviations.
• RA Input to Product Quality Reports (PQR).
• Support to Regulatory Compliance Files (RCF).

Requirements:

Education: 

• Advanced degree (Master’s or PhD) in Pharmacy, Life Sciences or a related field.

Experience:

• At least 5 years of experience from a similar RA position at HQ level.
• Solid understanding of GMP, development and commercial activities.
• Knowledge of European regulatory requirements, submission processes and interactions with regulatory authorities throughout Europe especially the Nordic countries where the majority of our products are registered.

Regulatory Knowledge: 

• Solid understanding of global regulatory legislation and guidelines.

Communication & Collaboration Skills: 

• Excellent written and verbal communication skills fluently in English.
• Foster strong working relationships with internal teams, external partners and competent authorities.
• Demonstrate excellent interpersonal skills to manage and resolve issues efficiently.

Attention to Detail: 

• High level of accuracy and attention to detail in all aspects of work.

What you39ll get in return

• Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
• Work in a hybrid model (3 days in the office per week)
• Potential for a permanent contract after an initial 3-month period.
• Comprehensive medical coverage through Medicover.
• Sports Card: Access to various sports facilities and activities.
• Life insurance coverage for added security.
• Opportunity to be involved in the transition of processes.
• Attractive and competitive salary.

Hays Poland sp. z o.o. jest agencją zatrudnienia zarejestrowaną w rejestrze prowadzonym przez Marszałka Województwa Mazowieckiego pod numerem 361.

Praca Warszawa

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