Regulatory Affairs Manager (12-month contract)

Job description

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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Live What you will do Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring for a Regulatory Affairs Manager (12-month contract with possibility of extension) for Amgen Australia. Live What you will do Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. 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. 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. IMR, PMCs, pediatric and other agency commitments). 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 Regional Regulatory Leads (RRLs) 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. Assists locally in Healthcare Compliance, QA or pharmacovigilance activities where applicable. Win What we expect of you 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 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. 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. Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being Vast 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 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Apply now for a career that defies imagination .