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 S&M 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
We offer concrete opportunities for professional growth through structured career paths, state-of-the-art instrumentation and ongoing training within a multinational context.
The remuneration package will be competitive and commensurate with the candidates’ experience.