Career Category

Job Description

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.

Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines. Today, serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to help people in fight against serious illness.

Our Budapest office is looking for a Regulatory Affairs representative.

Although we can offer only 1 year temporary contract, our intention is  to do the best to have a long term relationship.

What we can offer:

• Stable, leading biotechonolgy company

• Part of a great team

• Flexible working conditions with remote work opportunity

• Competitive compensation package

Local Regulatory Affairs colleague provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Local Regulatory Representative is assigned to one or more Amgen products and may support an LRR or lead a program under the supervision of an experienced Local Regulatory Lead. The product(s) assigned have low/medium complexity programs/strategies and medium impact to Amgen.

• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• 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.
• Act as the point of contact with regulatory agencies.

• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Creates, reviews and approves source text for country labeling, and owns the country artwork based on source text.
• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements.
• Monitors the external regulatory environment and changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.
• Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).
• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
• Participates in local regulatory process improvements, initiatives and training.

Requirements:

• Life science master’s degree
• 2-3 years experience in regulatory affairs
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• General knowledge of national legislation and regulations relating to medicinal products.
• Ability to work in teams.
• Ability to understand and communicate scientific/clinical information.
• Native Hungarian language
• Fluent English knowledge
• Ability to use IT platforms and MS tools
• Accuracy

Preferred requirements:

• Degree and in-depth regulatory experience
• Depth knowledge of country(ies) legislation and regulations relating to medicinal products.