LRR - Senior Associate Regulatory Affairs (Barcelona)

Amgen; España; On-site; EUR 41,000 - 55,000; Full time

Benefits offered by this job

Generous Total Rewards Plan

Flexible work arrangements

Job summary

Amgen in Spain seeks a Local Regulatory Representative (LRR), Sr. Associate to align local regulatory requirements with corporate standards and to drive regulatory submissions across affiliates.

You will review promotional materials, interact with regulatory agencies, and collaborate with brand teams to ensure compliance and timely product approvals. Fluency in Spanish and English is required, Portuguese is a plus.

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 would be a plus.
• Depth knowledge of legislation and regulations relating to medicinal products.
• 2 or more years of relevant work experience within the pharmaceutical industry.

Responsibilities

• Assist in aligning local regulatory requirements with Amgen's corporate standards.
• Provide national input to and execute regulatory strategies.
• Review promotional materials to ensure compliance with applicable regulatory requirements and company procedures.
• Serve as a member of brand teams, providing regulatory input and guidance.
• 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.
• 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 provides advice on local regulatory considerations/regulations in a timely manner.
• Participate in local regulatory process improvements, initiatives and training.

Skills

Spanish language

English language

Regulatory knowledge

Education

Degree in Pharmacy, Biochemistry, Biotechnology, Biology or related field

Master's degree in Pharmaceutical Industry desirable

Job description

Career Category

Regulatory

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Local Regulatory Representative (LRR), Sr. Associate

What You Will Do

Key responsibilities:

• Assist in aligning local regulatory requirements with Amgen's corporate standards.
• Provide national input to and execute regulatory strategies.
• Review promotional materials to ensure compliance with applicable regulatory requirements and company procedures.
• Serve as a member of brand teams, providing regulatory input and guidance.
• 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.
• 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 provides advice on local regulatory considerations/regulations in a timely manner.
• Participate in local regulatory process improvements, initiatives and training.

What We Expect Of 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 on Pharmaceutical Industry desirable
• Fluency in Spanish and English languages. Knowledge of Portuguese would be a plus.
• Depth knowledge of legislation and regulations relating to medicinal products
• 2 or more years of relevant work experience within the pharmaceutical industry

Soft skills:

• Ability to work in teams
• Attention to detail
• Strategic prioritization
• Solution oriented problem-solving skills

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also care deeply for our teammates' well-being and growth.

• Vast opportunities to learn, develop, and move up and across our global organization.
• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
• Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
• Flexible work arrangements.

EQUAL OPPORTUNITY STATEMENT

AMGEN is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Salary Range

40 943,65 EUR - 55 394,35 EUR