CMC Regulatory Compliance Specialist

Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.

Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a CMC Regulatory Compliance Specialist to join our R&D team at our Metamorfosi premises.

As a CMC Regulatory Compliance Specialist, the ideal candidate will be responsible for supporting all pre- and post- approval CMC activities and acts as a liaison person with all relevant departments within Pharmathen as well as suppliers.

Requirements

What you will do:

More particularly:

• Keeps abreast of international legislation, regulatory guidelines, and customer requirements.
• Collects and collates a wide range of product technical information and ensures compliance with all applicable quality and regulatory guidelines.
• Supports all pre-approval CMC activities by compiling product dossiers, including preparing and reviewing Modules 2 and 3, compiling Modules 4 and 5, and responding to Deficiency Letters (DLs) within established timelines.
• Supports post-approval CMC activities by preparing quality variation packages and renewals for DCPs, MRPs, CPs, and national applications, and by responding to relevant Deficiency Letters (DLs) within strict deadlines.
• Participates in teleconferences and meetings with regulatory authorities, suppliers, clients, and internal stakeholders across the organization.
• Actively participates, where relevant, in new product development and lifecycle management activities, including registered product variation strategy assessments, to ensure ongoing regulatory compliance.

The ideal candidate should have:

• Minimum of a bachelor’s degree in a scientific discipline (preferably Chemical Sciences, or Biochemistry)
• 5-7 years relevant experience in the pharmaceutical area
• Experience in analytical chemistry (e.g. HPLC) is considered an asset

Job-Specific Skills:

• Excellent communication in English language (writing & speaking)
• Ability to prioritize tasks and meet deadlines
• Computer literacy
• Project management
• Multi-tasking
• Time management

Benefits

What you'll gain:

• Involvement in a high-caliber, team-oriented and dynamic atmosphere
• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.