Regulatory Affairs Manager

AstraZeneca

Taiwan
Permanent
Full-time

13 days ago

Regulatory Affairs Manager leads and manages a team of regulatroy affairs staff. Responsible for staffskill development, performance management and resource allocation in order to ensure effective strategic and tactical input to local cross-functional teams and excellence in operational delivery. Leading a Regulatory Affairs Team with responsibility/accountability in the delivery of all Regulatory Projects and the management of issues related to Regulatory Affairs. Responsible for ensuring the delivery and implement strategies to gain rapid and high quality regulatory approvals and ensure regulatory compliance.Core Accountabilities

To lead the Regulatory Affairs Team and develop Regulatory personnel to meet AstraZeneca standards and proactive cross-functional teamwork contributing to optimum business strategies.
Lead and obtain/maintain Regulatory Authority approval of product registration application and market of AstraZeneca medicinal products in Taiwan.
To lead and implement Good Regulatory Practice (GRP) within Regulatory Affairs Team to ensure compliance.

Major ResponsibilitiesTo lead and obtain/maintain Regulatory Authority approval of product registration application and market AstraZeneca medicinal products in Taiwan

To plan strategically and prepare all necessary documentation to obtain marketing approvals at the earliest possible date.
To ensure all marketing authorizations are maintained in accordance with changes and comply with company standards.
To establish and maintain good relationship and partnership with Regulatory Authority and regulatory KOLs.
To monitor and interpret the local regulatory environment for significant changes and communicate the implications of such changes with key stakeholders. In addition, provide inputs to pre-launch new product planning as well.

To lead and implement GRP (Good Regulatory Practice) to ensure compliance within Regulatory Team

To ensure the GRP areas are rung in accordance with internal/external regulations and provide training for local Regulatory Affairs Team and follow up to fulfil the GRP requirements and company standards.
To contribute or lead the delivery of the local regulatory quality management system in line with expectations of global standards and procedures. Ensure compliance all staffs with relevant GXP requirements.
Monitoring KPIs in the related GRP area and proposing remedial and improvement actions.

To lead the Regulatory Team and develop Regulatory personnel to meet AstraZeneca standards

To Build an effective regulatory team
To coach and develop Regulatory staff to meet AstraZeneca standards.
To lead and develop Regulatory Function to deliver the best results and value to the business.

Qualifications

Ability to work effectively within and across a complex organisational matrix where s/he has no direct authority eg. Clinical Team, Medical Affairs Team, Marketing Team, Market Access Team, Sales Team, Finance Department, Enabling Team.
Ability to supervise others and maximize output through sharing expertise and experience is also necessary and to build employee capability to improve current and future productivity.
Regulatory knowledge and experience including working in a leading role at regulatory authority interface.
University education in bio/medical or pharmacy area.
At least 10 years previous experience in regulatory affairs in Pharmaceutical Industry
Demonstrated strategic thinking capability and an ability to critical evaluate risks to regulatory activities taking account of external trends in the regulatory and business environment.
Well-developed and proved leadership and ability to negotiate/influence others
Line management and staff development experiences

Date Posted 15-Apr-2024Closing Date 28-Jul-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

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