Regulatory Affairs Specialist (m/w/d)

Join Our Dynamic Consulting Team

At Techfirm Industrial Services, we are looking to expand our consulting team with a skilled professional in the field of Regulatory Affairs, particularly focusing on biosimilars and international product launches.

Location

Canton Zug

Contract Type

Consultant, limited duration

Key Responsibilities

• Manage regulatory affairs activities for biosimilars across multiple regions, ensuring compliance with national requirements for product launches.
• Coordinate regulatory documentation and submission dossiers in collaboration with affiliate Regulatory Affairs teams.
• Oversee and report progress of registration projects to ensure timely approvals and implementation.
• Support risk minimization measures, labelling activities, and regulatory compliance for assigned products.
• Build effective relationships with internal stakeholders, vendors, partners, and regulatory authorities.

Profile Sought

• Degree in pharmacy, chemistry, biology, pharmacology, or a related life sciences field.
• 3–5 years of experience in the pharmaceutical/biotech industry or scientific research, with at least 1 year in Regulatory Affairs.
• Experience in preparing regulatory submissions, amendments, or supplements.
• Strong communication and organizational skills, with the ability to work independently and as part of diverse teams.
• Cross-cultural awareness, sensitivity to international/multicultural environments, and knowledge of relevant regulations.
• Fluent verbal and written English is required.

If you are prepared to contribute to the regulatory success of innovative biosimilars projects in a multicultural environment, we encourage you to reach out for more details or to express your interest!