Line Manager / Regulatory Affairs Manager Switzerland

Resourcing Life Science; Schweiz; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

A leading life sciences consultancy is looking for a Regulatory Affairs Manager to oversee regulatory submissions, manage a team, and ensure compliance with EMEA and FDA regulations. Candidates should possess a minimum of 8 years in regulatory affairs, with at least 4 years in a managerial capacity. Excellent written and verbal English skills are essential for this role, which requires a commitment to work 4 days in the office in Switzerland.

Qualifikationen

• Minimum 8 years in regulatory affairs is required.
• At least 4 years as Regulatory Affairs Manager are needed.
• Experience with EMEA / FDA regulatory requirements is essential.
• Line management experience is ideal.
• Fluent English in written and verbal communication is mandatory.

Aufgaben

• Manage training of Regulatory Specialists and direct reports.
• Establish and oversee regulatory submission timelines.
• Engage with regulatory authorities for product registrations.
• Conduct global regulatory impact assessments for changes.

Kenntnisse

Regulatory submission management

Training and line management

Knowledge of EMEA / FDA requirements

Excellent communication skills

Jobbeschreibung

What to Expect

• Line management, training of Regulatory Specialist
• Training of direct reports in EMEA / FDA requirements
• Establish and manage regulatory submission timelines for both new and existing products across key global markets
• Engage with regulatory authorities and distribution partners to support product registrations
• Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
• Support and participate in inspections and audits conducted by global regulatory authorities.

Requirements

• Min 8 years in regulatory affairs
• Min 4 years as Regulatory Affairs Manager
• Experience with EMEA / FDA regulatory requirements
• Ideally line management of a team
• Excellent written and verbal in English
• Availability to work 4 days in office

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]

Tagged as: Regulatory Affair