Line Manager / Regulatory Affairs Manager Spain

Resourcing Life Science; España; Híbrido; PHP 1.500.000 - 2.300.000; Jornada completa

Descripción de la vacante

A global healthcare consulting firm is seeking an experienced Regulatory Affairs Manager to oversee regulatory submissions and manage a team. The role involves establishing submission timelines, engaging with regulatory authorities, and ensuring compliance with EMEA and FDA standards. Candidates should have at least 8 years in regulatory affairs, including 4 years in a managerial role, and be proficient in English. This position requires working 4 days in the office in Spain.

Formación

• Minimum 8 years in regulatory affairs.
• Minimum 4 years as Regulatory Affairs Manager.
• Experience with EMEA / FDA regulatory requirements.
• Ideally has line management experience.
• Excellent written and verbal communication skills in English.
• Availability to work 4 days in the office.

Responsabilidades

• Manage and train Regulatory Specialists.
• Establish and manage regulatory submission timelines.
• Engage with regulatory authorities for product registrations.
• Conduct global regulatory impact assessments.
• 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.

Conocimientos

Regulatory Affairs

Line Management

Knowledge of EMEA/FDA requirements

Excellent Communication Skills

Descripción del empleo

What to Expect

• Line management, training of Regulatory Specialist
• Training of the 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 the 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]