Regulatory Affairs Manager

Career Category

Job Description

Group Purpose

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

Job Summary

The Local Regulatory Representative (Manager) is assigned to one or more Amgen products. The product(s) assigned have 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.
• Develop, communicate and coordinate the regulatory strategy for pipeline
• Plan and manage clinical trial applications through CRO and liaise/coordinate CTA response to queries between CRO and Amgen.
• Manage CRO work invoice and participate in global network.
• Work as a primary point of contact and oversight for Global Regulatory Affairs & Safety (GRAAS) between the in-country Functional Service Provider (FSP) and Amgen, ensuring that the FSP delivers per contract as well as the timelines and quality of all regulatory and safety filings.

Key Activities

Strategic and Execution

• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
• 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 (where appropriate).
• Reviews and approves the promotional and non-promotional materials.
• Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to Amgen.
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
• Ensures/supports regulatory product compliance (e.g. RIM, PMCs, pediatric and other agency commitments, Renewal).

HEALTH AUTHORITY INTERACTIONS

• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Participates/contributes to local agency interactions and their preparation.

COMMUNICATION AND COLLABORATION

• Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
• Exchanges 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.
• Partners with International Regulatory Leads (IRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
• Partners with peers to ensure consistency on procedures.
• Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).
• Establishes regular contacts and interactions with Distributors (if applicable).

COUNTRY SPECIFIC ACTIVITIES

• Assists locally in Healthcare Compliance activities where applicable.
• Participates in local regulatory process improvements, initiatives and training.
• Oversees external vendor/contractor relationships where applicable.

Knowledge and Skills

Scientific and Technical

• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
• Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
• Understanding of drug development.

Others

• Demonstrate strong team work ability.
• Good communication skills - both oral and written.
• Good negotiation and Influencing skills.
• Ability to understand and communicate scientific/clinical information.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Cultural awareness and sensitivity to achieve results across both regional, country and International borders.

Education & Experience

Basic

• Doctorate or Master’s degree (scientific area) and 3 years of directly related experience OR Bachelor’s degree (scientific area) and 5 years of directly related experience

Preferred

• Degree and in-depth regulatory experience and/or related to the country(ies).
• Depth knowledge of country(ies) legislation and regulations relating to medicinal products.
• Experience in plan/submit/approval of New drug application
• Experience in clinical trial application and negotiation with MFDS.