Regulatory Affairs ManagerCambridge, GBRPosted 34 days ago

Kroes Communications; Cambridge; Hybrid; GBP 125,000 - 150,000; Full time

Job summary

A global biopharmaceutical company in Cambridge is seeking a Regulatory Affairs Manager to ensure compliance with regulatory requirements for clinical trials and product approvals. You will be responsible for managing submissions and developing regulatory strategies in collaboration with the team. The ideal candidate should have a scientific degree, strong communication skills, and experience in regulatory environments. This role offers flexibility to work from home with some days in the office.

Benefits

Growth opportunities

Diverse and inclusive community

Generous total rewards plan

Qualifications

• Demonstrated experience in a similar role.
• Experience working with policies, procedures and SOPs.
• Experience in the regional regulatory environment.

Responsibilities

• Ensure that Amgen acquires and maintains required licenses for clinical trials.
• Support regulatory submissions for products.
• Participate in developing regional regulatory strategies.

Skills

Strong communication skills

Knowledge of regulatory principles

Ability to understand scientific/clinical information

Ability to anticipate and prevent potential issues

Education

Scientific degree

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission to serve patients drives all that we do. We are a global collaborator achieving together research, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

REGULATORY AFFAIRS MANAGER - LIVE

What You Will Do

In this vital role you will work to ensure that Amgen acquires and maintains all required licenses 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.

Strategy and Execution

• 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 mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
• Support regional label negotiation activities.
• 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 under general supervision.

Regulatory Research

• 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, precedents and other information relevant to regional product advancement.
• Under supervision evaluate and communicate the impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.

Be part of our team

You will be joining the European General Medicine Regulatory team, part of the Global Regulatory Affairs function in Europe. You will work with colleagues responsible for leading the European regulatory strategies and submissions for development and marketed products from first-in-human clinical trials to marketing authorisation, and throughout the product lifecycle.

This team leads the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflammation, Endocrine and Bone disease areas, as well as pre‑approval filing activities for biosimilars.

What We Expect Of You

• Scientific degree and demonstrated experience in a similar role.
• Knowledge of regulatory principles.
• Experience working with policies, procedures and SOPs.
• Knowledge of legislation and regulations relating to medicinal products.
• Awareness of the registration procedures in the region for clinical trials, marketing authorisation, post‑approval changes, extensions and renewals.
• Knowledge of drug development.
• Experience in the 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.

What You Can Expect Of Us

• Growth opportunities to learn and move up and across our global organization.
• A diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.
• A generous total rewards plan comprising health, finance and wealth, work/life balance and career benefits.

LOCATION

Flexibility to work from home with a few days per month working from our Cambridge or Uxbridge office.

Apply Now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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.