Officer, Regulatory Affairs
Hikma Pharmaceuticals
Remoto
At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines.
Hikma intends to recruit an Officer, Regulatory Affairs (m/f) to integrate the Regulatory Affairs – Lifecycle, working on-site.
Main Responsibilities:
- Provide administrative support for day-to-day activities, such as handling of invoices, purchase orders, legalization of documentation, ...
- Support the site in the launch of new products by performing the required administrative regulatory activities, such as coordination of Safety Data Sheets and Export Licenses
- Prepare, review and implement labelling
- Liaise with and provide support to partners, suppliers, internal clients and Regulatory Authorities
- Open Change Controls and prepare variations/supplements of lower complexity
- Provide information for Annual Product Reviews (APRs)
- Create and revise internal SOPs and other relevante documentation from the department
- Technical certification or relevant academic background
- 1–2 years of relevant professional experience, preferably within the pharmaceutical industry
- Previous experience with packaging materials and/or labelling activities is considered an advantage
- Good command of English, both written and spoken
- Strong communication and interpersonal skills
- Proactive, responsible and collaborative approach
- Strong organizational and planning skills, with the ability to manage multiple priorities
- High attention to detail and accuracy
- Ability to work effectively under pressure and meet established deadlines
- Strong team player with the ability to collaborate effectively across different departments
- Direct contract with Hikma
- Competitive salary aligned with the role
- Life insurance
- Health Insurance extended to student children (up to age 24)
- Annual Performance Bonus
- Real Growth Opportunities