Senior Specialist, Regulatory Affairs (EU/RoW)

Cpl Life Sciences; Sankt Gallen; Hybrid; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

CPL Life Sciences is collaborating with a growing biotechnology company to advance therapies. We seek a Senior Specialist, Regulatory Affairs (EU/RoW) to drive regulatory submissions, planning, and lifecycle management across development and commercial programmes.

You will partner with internal teams, external vendors, and authorities, support CTAs/MAAs, ensure timely, compliant submissions, and help evolve regulatory processes in a fast-paced biotech environment. Hybrid, based in Switzerland.

Qualifikationen

• Minimum 4 years' experience in Regulatory Affairs in pharma/biotech.
• Experience with CTAs, MAAs and variations.
• Knowledge of ICH, EU and international guidelines.

Aufgaben

• Support regulatory submissions across EU and Rest of World.
• Coordinate CTAs, amendments, and annual reports.
• Prepare and review responses to regulatory questions.
• Contribute to MAAs and new indications in late-stage development.
• Ensure submissions are complete, compliant, and timely.
• Assist health authority interactions and coordinate with consultants.
• Maintain regulatory documentation and archiving systems.
• Collaborate with cross-functional teams to meet objectives.
• Monitor regulatory changes and provide intelligence.
• Help develop and improve regulatory processes and SOPs.
• Support broader Regulatory Affairs initiatives.

Kenntnisse

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory intelligence

Ausbildung

Bachelor's degree in Life Sciences or related

Advanced degree (MSc/PhD/PharmD) preferred

Tools

Veeva Vault

Jobbeschreibung

Job Title: Senior Specialist, Regulatory Affairs (EU/RoW)

Job Type: Full time, Permanent Position

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.
• 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.

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.