LRR - Senior Associate Regulatory Affairs (Barcelona)

Amgen; Barcelona; In loco; EUR 41.000 - 55.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Fluent Spanish

Fluent English

Teamwork

Attention to detail

Strategic prioritization

Problem solving

Formazione

Bachelor's degree in Pharmacy

Master's degree in Pharmaceutical Industry (desirable)

Descrizione del lavoro

Career Category Regulatory Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 LIVE

• 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.

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
• Soft skills: Attention to detail
• Soft skills: Strategic prioritization
• Soft skills: 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.

Salary

Salary Range 40 943,65 EUR - 55 394,35 EUR

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.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen