Position
: Regulatory Affairs Associate - Temporary
Location
: Madrid
Experience
: 3+ years of experience in similar roles within the pharmaceutical sector
Want to know more?
?
Exeltis is part of Insud Pharma, a integral pharmaceutical group operating across the entire value chain, with extensive expertise in scientific research, development, manufacturing, sales and marketing of a broad portfolio of pharmaceutical products that bring value to human and animal health.
Insud Pharma is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotech (mAbxience). With more than 10,000 professionals in over 50 countries, 20 industrial plants, 15 specialized R&D; centers, 12 commercial offices and more than 35 pharmaceutical subsidiaries, the group serves 1,150 customers in more than 110 countries worldwide. Innovation and sustainable development are at the heart of everything we do.
What are we looking for?
?
At Exeltis,
we are looking for a Regulatory Affairs Associate to provide regulatory leadership and overall management for LPRI projects developed for international markets. This person will play a key role in regulatory strategy definition, submission planning and agency interaction, ensuring high-quality filings and efficient approvals.
The challenge
?
- Provide regulatory leadership for LPRI projects intended for international markets.
- Develop and implement regulatory strategies for projects in development.
- Act as the main point of contact with regulatory agencies.
- Provide regulatory advice on clinical development and submission of marketing applications to European Health Authorities.
- Maintain a thorough understanding of EMA regulations related to medicinal products, medical devices or combination products.
- Share regulatory updates from EMA and other relevant international markets, including the US, with partners and collaborators.
- Plan and oversee the preparation of all regulatory filin
📌 Regulatory Affairs Associate (Madrid)
🏢 Insud Pharma
📍 Madrid
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