(Senior) Specialist - RA Life Cycle Management CMC

Orifarm is seeking a (Senior) Specialist - RA Life Cycle Management CMC to ensure regulatory compliance throughout the lifecycle of marketing authorisations. You will develop and execute regulatory strategies, prepare regulatory variation packages, and author the CMC sections of dossiers.

The role requires a deep understanding of pharmaceutical manufacturing processes, analytical testing, and pharmaceutical legislation, coupled with strong communication skills. You will collaborate closely with chemists, formulation specialists, and cross‑functional teams to manage variations and maintain uninterrupted supply.

Main tasks and responsibilities

• Develop and implement regulatory strategies for CMC variations.
• Stay updated on current regulatory legislation, guidelines and best practices related to CMC.
• Provide regulatory guidance and support to cross‑functional project teams.
• Coordinate and compile required documentation, ensuring accuracy, completeness and compliance.
• Review manufacturing changes, analytical methods and process validations to ensure regulatory compliance.
• Prepare and review CMC sections of regulatory dossiers and variation packages.
• Manage timelines and ensure timely submission of regulatory variation packages.
• Act as the primary contact for competent authorities and facilitate communication to resolve issues and obtain approvals.
• Prepare responses to regulatory questions and support regulatory compliance files.
• Support daily operation tasks such as change controls, deviations and input to product quality reports.

Who are you?

• Advanced degree (Master’s or PhD) in Pharmacy, Life Sciences or a related field.
• At least 3 years of experience at HQ level in a similar RA position.
• Solid understanding of GMP, development and commercial activities.
• Knowledge of European regulatory requirements, especially in the Nordic countries.
• Solid understanding of global regulatory legislation and guidelines.
• Excellent written and verbal communication skills fluent in English.
• Strong working relationships with internal teams, external partners and competent authorities.
• Excellent interpersonal skills to manage and resolve issues efficiently.
• High level of accuracy and attention to detail.

What we offer

• Life insurance
• Private medical care
• Sports card
• PPK
• Annual bonus

Job location

Warsaw, Poland. Hybrid work model – 3× week from the office located in Gdański Business Center, Inflancka 4.

Travel: occasionally. Start reviewing applications in November.

Why work for Orifarm?

Orifarm values flexibility, work‑life balance and a collaborative environment. With our international setting, you will have growth and advancement opportunities, and you will help deliver affordable, high‑quality pharmaceuticals worldwide.

About Orifarm

Founded in 1994, Orifarm is Europe’s largest parallel importer of pharmaceuticals. We are committed to making modern medicine accessible and affordable. Our mission is to bring healthy days by creating access to high‑quality products, driving innovation, and protecting patient welfare.

For as many as possible, as healthy a day as possible.

Eligibility

We encourage people from all backgrounds. Our commitment to diversity ensures a welcoming and inclusive workplace.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance

Industry

Pharmaceutical Manufacturing