LRR - Senior Associate Regulatory Affairs (Barcelona)
About this opportunity
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
LIVE
What You Will Do
In this role you will support marketed products under the supervision of an experienced Local Regulatory Lead.
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.
WIN
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:
What will help you succeed in this role
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
THRIVE
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.
APPLY NOW
Objects in your future are closer than they appear. Join us.
CAREERS.AMGEN.COM
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
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 118 comparable Senior Regulatory Affairs roles across 45 biopharma companies.
Salary context
35 of 118 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 118 comparable roles
+ 17 more countries
Seniority mix
118 of 118 peers have a known seniority level
Therapeutic area mix
18 of 118 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Regulatory Affairs job in Spain, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.