Regulatory Affairs - CMC Specialist

Job offer

At PharmaSwiss, an international pharmaceutical company and part of the Bausch Health group, we are looking for a Regulatory Affairs - CMC Specialist to join our EMEA Regulatory CMC team in Prague.

If you are interested in regulatory affairs within an international pharmaceutical environment and would like to work on diverse products across their full lifecycle, this role offers an excellent opportunity to further develop your expertise and grow professionally in a collaborative and supportive environment.

Your mission

In this role, you will independently manage regulatory CMC activities for pharmaceutical products and drug substances throughout their lifecycle. You will cooperate closely with cross-functional teams across Regulatory Affairs, Quality, Manufacturing, Supply Chain, and external partners to ensure high-quality regulatory submissions and compliance with regulatory requirements across the EMEA region.

What you will do

• Independently manage regulatory CMC activities for assigned pharmaceutical products and projects
• Prepare, author, review, and coordinate quality documentation for pre-authorization and post-authorization submissions
• Support regulatory strategies related to new marketing authorization applications and lifecycle maintenance activities
• Coordinate and drive CMC submission activities, including planning and execution
• Collaborate with interdisciplinary project teams and communicate regulatory strategies and key topics across the organization
• Review and assess quality and technical documentation from licensors and contract manufacturing organizations (CMOs)
• Provide regulatory CMC support during internal and external inspections and audits
• Participate in due diligence and quality compliance activities
• Monitor regulatory developments and ensure compliance with current regulatory requirements and guidelines
• Contribute to continuous improvement of regulatory processes and documentation standards

What we are looking for

• University degree in Chemistry, Pharmacy, Life Sciences, or a related field
• Previous experience in the pharmaceutical industry, Regulatory Affairs, Quality, Documentation, or Health Authority environment is preferred, but not strictly required
• Knowledge of Regulatory Affairs CMC and registration procedures within the EMEA region is an advantage
• Ability to work independently, prioritize tasks, and manage multiple activities simultaneously
• Strong analytical thinking and attention to detail
• Proactive and solution-oriented mindset
• Ability to collaborate effectively within multinational and multifunctional teams
• Excellent communication and interpersonal skills
• Fluency in English, both written and spoken

What we offer

• Opportunity to work in an international pharmaceutical company with exposure to diverse products and regulatory projects
• Meaningful and independent work with visible impact on business operations
• Cooperation with experienced professionals in an international environment
• Professional growth and continuous learning opportunities within Regulatory Affairs
• Competitive salary and annual performance-based bonus
• Employee benefits package
• 5 weeks of vacation + 5 sick days
• Hybrid working model with the possibility to work from home on Mondays and Fridays
• Modern offices in Prague
• Supportive and collaborative team culture

If you are not contacted within 14 days of submitting your CV, you were not selected for the next round of the recruitment process.

By submitting your CV to PharmaSwiss, s.r.o., you consent to the processing and storage of your personal data for recruitment purposes until this consent is withdrawn.