Job Description

REGULATORY AFFAIRS MANAGERDo you have expertise in, and passion for Regulatory Affairs? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!ABOUT ASTRAZENECAAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world\xe2\x80\x99s most serious diseases. But we\xe2\x80\x99re more than one of the world\xe2\x80\x99s leading pharmaceutical companies. We are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear \xe2\x80\x93 shaping the future by spotting a scientifically-led commercial opportunity and acting now to operationalise and scale it.Our Singapore Marketing Company (SGMC) is responsible for the marketing of our medicines in Singapore. Here you\xe2\x80\x99ll also find colleagues from AstraZeneca\xe2\x80\x99s corporate functions and our Asia and International regions\xe2\x80\x99 sales and marketing teams. As a member of the Singapore Association of Pharmaceutical Industries (SAPI), all of our sales, marketing and communications activities are subject to the SAPI Code of Conduct.BUSINESS AREA \xe2\x80\x93 Singapore Marketing Company, Regulatory AffairsOur team proudly leads the way as the fastest growing pharmaceutical. But we\xe2\x80\x99re not done yet \xe2\x80\x93 we\xe2\x80\x99re fearless in setting the direction for a new future to keep progressing for our patients. We\xe2\x80\x99re bringing transformative drugs to those that need them the most by combining continuous new launches with unique solutions across the whole patient journey. It\xe2\x80\x99s how we are able to truly make a difference to the quality of lives and answer huge unmet patient needs.In our ever-evolving and complex markets, it takes entrepreneurial thinking to stay at the forefront. Fusing our diverse minds with local ownership we\xe2\x80\x99re powered with everything we need to shape a new future for AstraZeneca, our markets and our patients.United by our local sense of belonging, there\xe2\x80\x99s never been a better time to a join a progressing team. Countless opportunities to learn from the best global talent, this is a place for those who want to be challenged and empowered to do the things they never thought possible.What you\xe2\x80\x99ll doYou\xe2\x80\x99ll develop and implement regulatory strategies to gain rapid and high-quality approvals and ensure regulatory compliance, in order to achieve company\xe2\x80\x99s business objectives. You\xe2\x80\x99ll also develop and implement quality assurance processes including good regulatory practices within AZ, aligned with local and global requirements to maintain licence to operate.Essential for the role

• Bachelor\xe2\x80\x99s degree in Pharmacy/related field
• Minimum 5 years\xe2\x80\x99 experience in regulatory affairs for product registration
• Collaborative and cross-functional team working skills to coordinate and influence multiple teams (commercial, medical, market access)
• Strong interpersonal skills to develop good relationships with stakeholders
• Good influencing skills
• Demonstrated project management (good planning and organisational skills)
• Self-motivated, individually driven and able to work independently
• Ability to work effectively under pressure

Desirable for the role

• Registered pharmacist
• Master\xe2\x80\x99s degree
• Experience in area(s) of vaccines and/or medical devices
• Experience in Regulatory operations, GxP compliance and/or regulatory policy would be an advantage
• Experience in similar position in MNC pharmaceutical company

Depending on candidate experience, this position may be filled at the following levels: Executive, Senior Executive, Associate Manager, Manager or Senior Manager.Why AstraZeneca?At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We\xe2\x80\x99re on an exciting journey to pioneer the future of healthcare.So, what\xe2\x80\x99s next?

• Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it\xe2\x80\x99s yours.

Date Posted 05-Apr-2024Closing Date 18-Apr-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca