Senior Regulatory Affairs - Local Submissions (Barcelona)

Amgen; Barcelona; Sur place; EUR 41 000 - 55 000; Plein temps

Résumé du poste

Amgen in Barcelona is seeking a Local Regulatory Representative Sr. Associate to align local regulations with corporate standards and manage regulatory submissions.

You will work with cross-functional teams to ensure labeling and materials meet regulatory requirements and interact with agencies as needed. The role requires a Pharmacy or related degree, 2+ years in pharma, and fluency in Spanish and English.

Qualifications

• Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field.
• Master's degree in Pharmaceutical Industry desirable.

Responsabilités

• Align local regulatory requirements with Amgen's corporate standards.
• Provide national input to regulatory strategies and plan local submissions.
• Review promotional materials for regulatory compliance.
• Serve on brand teams providing regulatory input and guidance.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards.
• Interact with regulatory agencies and manage on-time submissions.

Connaissances

Fluent Spanish

Fluent English

Teamwork

Attention to detail

Strategic prioritization

Problem solving

Formation

Bachelor's degree in Pharmacy

Master's degree in Pharmaceutical Industry (desirable)

Description du poste

Amgen in Barcelona is seeking a Local Regulatory Representative Sr. Associate to align local regulations with corporate standards and manage regulatory submissions.

You will work with cross-functional teams to ensure labeling and materials meet regulatory requirements and interact with agencies as needed. The role requires a Pharmacy or related degree, 2+ years in pharma, and fluency in Spanish and English.