Officer, Regulatory Affairs

Hikma Pharmaceuticals; Sintra; Presencial; EUR 28.000 - 42.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Direct contract with Hikma

Life insurance

Health Insurance extended to student

Annual Performance Bonus

Real Growth Opportunities

Descripción de la vacante

Hikma Pharmaceuticals is seeking an Officer, Regulatory Affairs (m/f) to join the Regulatory Affairs – Lifecycle team on-site in Portugal. This role supports day-to-day regulatory activities, labeling, and liaison with authorities to ensure compliant product launches.

The ideal candidate has 1–2 years in pharma regulatory work, strong English skills, and a proactive, collaborative mindset. Direct contract with Hikma includes life and health insurance and annual bonus opportunities.

Formación

• Technical certification or relevant academic background.
• 1–2 years of regulatory experience in pharma is preferred.
• Good command of English, both written and spoken.
• Strong organizational and planning skills.
• Ability to work under pressure and meet deadlines.

Responsabilidades

• Provide administrative support for day-to-day regulatory activities.
• Coordinate labeling and packaging materials with Regulatory Authorities.
• Prepare, review and implement labelling.
• Liaise with partners, suppliers and internal clients.
• Open Change Controls and prepare variations of lower complexity.
• Prepare information for Annual Product Reviews.
• Create and revise SOPs and department documents.

Conocimientos

Regulatory knowledge

English proficiency

Communication skills

Organizational skills

Team collaboration

Proactive approach

Educación

Technical certification or relevant academic background

Descripción del empleo

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

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

Profile:

• 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

We offer:

• 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

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day