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Senior Specialist, Regulatory Affairs Life Cycle Management
4 months ago
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Senior Specialist, Regulatory Affairs Life Cycle ManagementCategory: Regulatory Affairs
Country/Region: DK
Location:
Odense, DK, 5260 Søborg, DK, 2860
– Dedicated RA specialist with strong quality focus and an eye for Life Cycle ManagementWe are looking for a dedicated specialist within Life Cycle Management (LCM). You should possess a positive drive and a background in chemical and pharmaceutical sciences, aiming to leverage your knowledge and experience in a dynamic environment with great opportunities for professional and personal growth. You are focused, detail-oriented, and capable of independently managing and structuring various tasks. Furthermore, you are comfortable working with internal and external stakeholders from diverse backgrounds, you confidently contribute your expertise and foster a collaborative and open working environment.
About the job
We are currently looking for a Senior Regulatory Affairs Life Cycle Management (RA LCM) Specialist for our CMC team. In this role, you will in collaboration with the team be responsible for managing the regulatory aspects of our generic portfolio after receival of the marketing authorization, ensuring compliance with current legislation throughout the product lifecycle.
It is a full-time position from the 1st of September 2024 or as soon as possible thereafter. You will be working at either our headquarters in Odense or our Søborg office, with the flexibility to work partially from home. You will collaborate closely with local RA across Europe, global suppliers, European authorities, and internal departments including Quality, Supply Chain, Labelling, and Portfolio Management.
Key responsibilities:
- Handling module 3 variations
- Review and/or author CMC documentation
- Contribute to the development and implementation of regulatory strategy
- Initiate internal change controls
- Cooperate with internal and external stakeholders (authorities, external suppliers, different departments in Orifarm etc.)
- Maintain compliance with European legislation
Who are you?
The right match for this position is a Pharmacist, Cand. scient. in Chemical Engineering, Chemistry, Biochemistry, or similar, with 7-8 years of experience in RA. Experience in CMC, either in Development or Life Cycle Management, is preferred.
You should have a comprehensive understanding of regulatory documentation and experience with regulatory authorities in Europe. Moreover, you should have strong IT/digital skills.
As a person, you are:
- Skilled in managing multiple tasks and deadlines in a structured manner
- A team player who can take responsibility and work independently
- Excellent in communication, with fluency in written and spoken English
- Strong in collaboration, capable of working effectively with diverse groups of people
- Highly analytical and possess excellent coordinating abilities
- Able to focus on both details and the bigger picture
Who are we?
We are a team of 11 skilled and dedicated regulatory professionals situated in Odense and Søborg. We value a casual, positive, and humorous social atmosphere, making room for both laughter and serious discussions. Our working environment is exciting and dynamic, characterized by individual responsibility and mutual support. We help each other and provide professional and personal sparring to ensure everyone's success and growth.
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 13 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 operate within seven business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel Import and Clinical Trials Supplies (CTS). Further, we focus heavily on new business opportunities and synergistic M&A to expand our offerings.
We offer
At Orifarm, we know that our growth comes from the development of our employees. We are an ambitious organization with an entrepreneurial culture that celebrates can-do attitudes, smarts, and hearts. Our secret to success? Valuing how different skill sets join forces to make our journey happen. Whether you play a direct or indirect part in fulfilling our purpose, you get to contribute and use your personal and professional skills. Indeed, at Orifarm, your personal growth journey is shaped only by your contribution to making healthy days for as many people as possible.
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.
Job Location
Mainly depending on your preferences, the job will either be located at our headquarter in 5260 Odense or at our office in 2860 Søborg.
Need further information?
If you need further information about the job, please contact Department Manager, RA LCM, Sofia Mikkelsen Berg at .
We are often looking for new employees to help us grow and therefore, we may have other interesting opportunities for you. Follow us on LinkedIn to receive updates on our business activities and job opportunities:
As soon as possible. Interviews will be held on an ongoing basis.
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