Regulatory Affairs Manager

Regulatory Affairs Manager

Career Category:
Regulatory

In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. You will support one or more products from a regional regulatory perspective.

• Plan and manage regulatory submissions (e.g., clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
• Under general supervision, implement product‑related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
• Support regional label negotiation activities.
• Under general supervision participate in the development, and execution of regional regulatory product strategies.
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.

• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
• Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.

• Scientific degree and demonstrated experience in a similar role.
• Regulatory principles
  • Working with policies, procedures and SOP’s.
  • Knowledge of legislation and regulations relating to medicinal products.
  • Awareness of the registration procedures in region for clinical trials, MA, post‑approval changes, extensions and renewals.
• Knowledge of drug development.
• Knowledge of and experience in regional regulatory environment.
• Strong communication skills - both oral and written.
• Ability to understand and communicate scientific/clinical information.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

• Growth opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

The expected gross pay range for this role in Portugal is EUR 48,957.00 to 66,237.00. Actual pay will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.