(Senior) Specialist - RA Life Cycle Management CMC

The (Senior) Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory requirements during the lifecycle management of Orifarm’s 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.

Main tasks and 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.
• Input to deviations.
• RA Input to Product Quality Reports (PQR).
• Support to Regulatory Compliance Files (RCF).

Who are you?

• Advanced degree (Master’s or PhD) in Pharmacy, Life Sciences or a related field.
• At least 3 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.
• Solid understanding of global regulatory legislation and guidelines.
• 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.
• High level of accuracy and attention to detail in all aspects of work.

Who are we?

We are two teams of 8 and 12 skilled and dedicated regulatory professionals located in Odense and Søborg (Denmark) and Warsaw (Poland).

We value a relaxed, positive, and humorous atmosphere, where there’s room for both laughter and focus. Our working environment is dynamic and engaging, characterized by a strong sense of ownership and collaboration. Everyone takes responsibility for their own tasks while actively supporting and sparring with colleagues—both professionally and personally.

What we offer:

• Fulltime employment contract
• Life insurance
• Private medical care
• Sports card
• PPK
• Hybrid work model
• Flexible working hours

Job Location

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

Travel: occasionally

Application deadline

As soon as possible. Please note that we will start reviewing applications in November.

Why should you work for Orifarm?

At Orifarm, we know that our growth comes from the development of our employees. We are an ambitious organization with an entrepreneurial culture celebrating can-do attitudes, smarts, and hearts. Our secret to success? Valuing how different skill sets join forces to make our journey happen.

You will experience a work environment characterized by flexibility and a strong commitment to work-life balance, understanding that the best results come from satisfied and well-supported employees. Our international setting offers great opportunities for growth and career advancement. We also prioritize social events and gatherings to ensure that our employees feel connected and engaged with each other.

We regard our feedback culture as a fundamental element in the individual employee's opportunities for learning and development. When we have good results, every employee, including student workers, is part of our bonus scheme.

About Orifarm

Everyone should have access to modern medicine. High costs or lack of access to pharmaceuticals should never impact our possibility to receive treatment or relief and live a healthy life. At Orifarm, we aim to bring healthy days by making modern healthcare a better deal for the people and the societies we serve. Working towards our vision, we create access to affordable, high-quality pharmaceuticals and healthcare products by challenging markets and always seeking new opportunities. With our core values paving the way, we always act responsibly and constantly with our customers at the center of our attention. And everything we do is driven by our sole purpose:

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

Our history goes back to 1994 when Orifarm was founded in Denmark by Hans and Birgitte Bøgh-Sørensen. Since then, Orifarm has grown from a small nine-person company into an international company operating globally in 15 countries. Today, Orifarm is Europe's largest parallel importer of pharmaceuticals and Denmark's largest supplier of pharmaceuticals, with more than 2,200 employees.

We encourage everyone to apply

At Orifarm, we welcome people from all backgrounds, recognizing that the best outcomes come from a diverse and inclusive work environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable future. By creating such an environment, we are confident that we can achieve better results together.