Job description
Overview:
Mithra is looking for a Regulatory Affairs Leader to join its R&D Department to work at Mithra headquarter (Liège). Responsibilities:
Qualifications:
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium. www.mithra.com
Mithra is looking for a Regulatory Affairs Leader to join its R&D Department to work at Mithra headquarter (Liège).
Mithra Pharmaceuticals is looking for a talented, experienced regulatory affairs expert to join the Regulatory Affairs team. Reporting to the Head of Global Regulatory Affairs, the RA leader provides support for the implementation and execution of regulatory strategy and health authority interaction, and coordination of regulatory submissions and post-approval life-cycle management with internal and external partners worldwide.
The role may evolve with the new challenges however core responsibilities will include:
- Ensure marketing authorizations and lifecycle management are compliant with regulatory requirements.
- Define and/or coordinate the preparation of new submissions and variations and defining the regulatory strategy for submission worldwide.
- Manage European submissions (variations, renewals,…), assuring timely execution and compliance.
- Manage publishing, submitting and archiving of documents.
- Provide support to local partners for the preparation of local submissions, and assure timely execution and compliance.
- Review product labelling/packaging texts.
- Ensure timely and pro-active communication of the authorization status within the organization.
- Collaborate with internal and external stakeholders, including local Health Authorities when appropriate.
- Review the regulatory aspects included in contractual proposals with potential partners.
- Manage regulatory-related work/purchase orders.
- Build and sustain a positive relationship with the health authorities and local partners.
- Follow-up of regulatory legislation; evaluate impact on business.
- Provide regulatory requirements and intelligence to Regional and European organization.
Qualifications:
- University degree – medical or paramedical (pharmacy, biology, veterinary, biomedical Sciences) or equivalent by experience
- Minimum 5 years’ experience in a similar function
- Experience with EU regulatory procedures (CP, MRP/DCP, NP) and post-marketing regulatory framework
- Experience in working in cross-functional project teams and within a collaborative team environment
- Excellent oral and written communication skills
- Excellent interpersonal, negotiation and communication skills
- Fluent in English and French (speaking, reading and writing)
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