Olon Group is a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and biological processes while always embracing the highest international safety, quality, and environmental standards.
Olon has a global network of 14 manufacturing sites and 9 RCD centers across the globe.
The successful candidate, reporting directly to the Regulatory Affairs Manager, will collaborate on the preparation and filing of API registration technical documentation for manufacturing sites managed by the Regulatory Affairs function.
The main activities of responsibility will be:
- Collaborating on the drafting and filing of DMFs and authorization/registration petitions at AIFA
- Collaborating on the drafting and filing of DMFs in the various countries of interest according to national regulations in support of the business
- Preparing responses to Deficiency Letters received from regulatory agencies using the support of other Corporate Functions
- Collaborate with the SCM Function for technical, scientific and regulatory support to clients
- Evaluating the regulatory impact in the area of change control
- Updating periodically the regulatory documentation filed at Worldwide Ministries and provided to clients
- Supporting the Manager and other RA specialists during audits of clients and ministries
The ideal candidate:
- has a bachelor’s degree in Chemistry, Pharmacy, Pharmaceutical technology
- has 2/3 years of experience as an RA Specialist in the field of Active Principles (API)
- has excellent English language skills (spoken and written)
- Complete the profile a strong customer (internal/external) and service quality orientation, ability to plan work, proactive spirit and excellent interpersonal skills
You will find:
- A dynamic, constantly evolving work environment, open to creativity and personal contribution
- Training Program to increase your personal and professional skills
- Courses for recent high school graduates and graduates
- Internal career paths: we believe in internal growth and cultivate our managers
- An inclusive environment that fosters integration of different cultures and mindsets
Olon is committed to providing equal opportunities in employment. Our policy foresees that equal employment opportunities are provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status and/or any legally recognized status entitled to protection under applicable local laws.
