The posting
Join Orifarm as our new RA Specialist and play a key role in managing regulatory variations, contributing to CMC strategies, and acting as a trusted regulatory partner
About the job
This position is a parental cover, expected to run for approximately a year. You can be based in Odense or Søborg, Denmark, or in Warsaw, Poland.
As our RA Specialist you will be 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.
As our RA Specialist you 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:
- 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
- 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 and variation packages
- Manage timelines and ensure timely submission of regulatory variation packages
- Act as the primary contact for competent authorities and prepare responses to regulatory questions
- Facilitate communication with regulatory authorities to resolve issues and obtain necessary approvals
- Daily operations tasks: Change controls, variations, input to deviations, RA Input to Product Quality Reports (PQR) and support to Regulatory Compliance Files (RCF)
Who are you?
We imagine that you have:
- An 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
- A 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
- A solid understanding of global regulatory legislation and guidelines
- Excellent written and verbal communication skills in fluent English
- Stakeholder management skills to foster strong working relationships with internal teams, external partners and competent authorities
- Excellent interpersonal skills to manage and resolve issues efficiently
- A high level of accuracy and attention to detail in all aspects of work
Who are we?
We are two teams of skilled and dedicated regulatory professionals located in Odense, Søborg and Warsaw. We value a relaxed, positive, and humorous atmosphere, where there is 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.
Why should you join Orifarm?
At Orifarm, we are 2,300 employees united by a shared purpose: improving access to affordable medicine for the people who need it. Founded in Odense, Denmark in 1994 by Birgitte & Hans Bøgh-Sørensen, we have built our business on challenging conventional thinking to make affordable high-quality pharmaceuticals more accessible across Europe. Rather than developing new medicines, we focus on finding smarter ways to bring existing treatments to patients, creating value for pharmacies, healthcare systems, and society.
We live by the mindset Challenge Accepted. It reflects our explorer spirit and can-do attitude, where challenges are perceived as opportunities. We encourage people to ask questions, challenge assumptions, and take ownership. Across teams, functions, and markets, you will find a collaborative and supportive culture built on trust, respect, and a flat hierarchy where everyone has a voice and direct access to decision-makers.
When you join Orifarm, you will be empowered to make a real impact from day one. We offer autonomy and great opportunities for career advancement, enabling our employees to shape their professional development. We value flexibility and provide a hybrid work model with the possibility of working from home two days a week.
We invite you to join Orifarm, if you are curious, ambitious, and accept the challenge of bringing better deals of medicine to millions.
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.
Application deadline
As soon as possible. Applications will be reviewed on an ongoing basis until the position is filled.
Apply now »
