Regulatory Affairs Specialist

hace 4 semanas

Barcelona, Barcelona, España Amgen A tiempo completo

Senior Associate Regulatory Affairs

About the Role:
In this role, you will support marketed products and investigational in vitro diagnostic medical devices to be used in combined trials under the supervision of an experienced Local Regulatory Lead. Key responsibilities include:

• Aligning local regulatory requirements with Amgen's corporate standards.
• Providing national input to and executing regulatory strategies.
• Planning and managing local regulatory submissions in compliance with corporate standards and local regulatory requirements.

Responsibilities:
• Assist in aligning local regulatory requirements with Amgen's corporate standards.
• Provide national input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Enable regulatory agencies' interactions.
• Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for IVD performance studies in accordance with national regulatory requirements.
• Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.
• Create, review, and approve source text for country labeling, and own the country artwork based on source text.
• Act as the point of contact with regulatory agencies in fulfilling local obligations.
• Participate/contribute to local agency interactions and their preparation.
• Work closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
• Exchange regulatory information and intelligence with other regulatory colleagues and cross-functional teams on an ongoing basis and provide advice on local regulatory considerations/regulations in a timely manner.
• Participate in local regulatory process improvements, initiatives, and training.

About You:
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Qualifications: Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field. Master's degree in Pharmaceutical Industry desirable.
• Fluency in Spanish and English languages. Knowledge of Portuguese language is desired.
• Knowledge of legislation and regulations relating to medicinal products and in vitro diagnostic medical devices.
• 2 or more years of relevant work experience within the pharmaceutical industry.

• Skills: Ability to work in teams. Attention to detail. Prioritization skills. Solution-oriented problem-solving skills

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