Job Title: Senior Specialist, Regulatory Affairs (EU/RoW)
Job Type: Full time, Permanent Position
Job Location: St Gallen, Switzerland (Hybrid)
CPL Life Sciences is collaborating with a growing biotechnology company focused on advancing innovative therapies for patients with unmet medical needs.
We are seeking an experienced Senior Specialist, Regulatory Affairs (EU/RoW) to support global regulatory activities across development and commercial programmes. This role will play a key part in regulatory submission planning, execution, and lifecycle management, while partnering closely with internal stakeholders, external vendors, and regulatory authorities.
This is an excellent opportunity for a regulatory professional looking to broaden their experience within a dynamic and collaborative biotech environment.
Key Responsibilities:
Support regulatory leads in the preparation, submission, and maintenance of regulatory applications across EU and Rest of World territories.
Coordinate and contribute to Clinical Trial Applications (CTAs), CTA amendments, pre- and post-authorisation submissions, and annual reports.
Assist in the preparation, review, and submission of responses to questions from regulatory authorities.
Participate in late stage development activities including initial and new MAAs and potentially any new indications.
Ensure all regulatory submissions are complete, compliant, appropriately formatted, and delivered within agreed timelines.
Support interactions with health authorities and coordinate activities with external consultants and service providers where required.
Maintain regulatory documentation, record management, and archival systems.
Partner effectively with cross-functional teams to support submission and development objectives.
Monitor evolving regulatory requirements and communicate relevant regulatory intelligence to support strategic decision-making.
Contribute to the development and continuous improvement of regulatory processes, tools, and SOPs.
Support broader Regulatory Affairs initiatives and departmental activities as required.
Requirements:
Bachelor's degree in Life Sciences, Biological Sciences, Pharmacy, or a related scientific discipline.
Advanced degree (MSc, PhD, PharmD, or equivalent) preferred.
Experience:
Minimum of 4 years' experience in Regulatory Affairs within the pharmaceutical, biotechnology, or health authority environment.
Strong understanding of the drug development lifecycle and regulatory requirements across product development and commercialisation.
Experience preparing and reviewing regulatory submissions including:
Clinical Trial Applications (CTAs)
Marketing Authorisation Applications (MAAs)
Variations and lifecycle management submissions
Experience interpreting and applying relevant ICH, EU, and international regulatory guidelines.
Demonstrated ability to assess regulatory issues independently and provide practical, risk-based recommendations.
Skills & Competencies
Excellent project management and organisational skills with the ability to manage multiple priorities simultaneously.
Strong analytical and problem-solving capabilities.
High attention to detail and commitment to quality.
Excellent verbal and written communication skills.
Strong interpersonal skills and ability to work effectively within cross-functional and international teams.
Proactive, self-motivated, and comfortable working within a fast-paced biotech environment.
Ability to adapt to changing priorities and business needs.
Experience with regulatory document management systems; experience with Veeva Vault would be advantageous.
If you are a Regulatory Affairs professional looking to further your career within a growing biotechnology organisation, please reach out to [email protected]
This role does not offer job sponsorship and you MUST already be based and living in Switzerland and be able to travel to site on a hybrid basis.