Regulatory Affairs Partner (1 Year Contract)

Purpose of the role :

Contributing towards accelerating access to Roche innovations in line with overall strategic objectives that will enable value creation for patients at lesser cost to the society.

Assisting with the preparation of document packages for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license renewals and regulatory related activities.

Supporting the Regulatory Affairs team in the operation and maintenance of relevant systems and processes, and ensuring the compliance to company requirements.

Key Responsibilities :

1. Supports the Regulatory Affairs function in the realization of regulatory strategy.
2. Coordinates the collection of documents, records, reports and data from various departments for inclusion in regulatory documents.
3. Helps with the preparation of submissions for product approval including NCEs, import licenses to Macau and applications to the Greater Bay Area.
4. Assists in the review of product labeling / advertising to ensure compliance with regulations.
5. Supports the running and operation of regulatory processes and systems.
6. Keeps abreast of regulatory procedures and changes in industry practices.
7. Duties as assigned to support the License to Operate Team and the affiliate.

Who you are : Qualifications

1-3 years of Hong Kong drug regulatory affairs experience preferred.

Bachelor's degree or above in a Science related discipline.

Capabilities

1. Attention to detail and high level of accuracy in executing regulatory affairs tasks.
2. Adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance and therefore playing a key role in retaining Roche Hong Kong and Macau’s License to Operate.
3. Problem solving skills and ability and excel under a high performing environment.

Mindset & Behaviors

1. Embrace the Roche Values of Integrity, Courage & Passion.
2. Demonstrate Roche Leadership Commitment & Core Competencies.
3. VACC - Embrace and master VACC (visionary, architect, coach, catalyst) behavior.
4. Growth - Ability to learn and unlearn quickly, take risks and experiment, and contribute to the learning cycle by sharing knowledge with others inside and outside Roche.
5. Value creation - Boldly act on key decisions and opportunities and boldly stop any activity that is not adding value. Ability to say “No” to stakeholders when the value is not predictable / foreseen.
6. Digital - Be Innovative and drive digital transformation across organizations and industries to bring value and impact to the healthcare ecosystem.
7. Enterprise - Think from an enterprise level, beyond boundaries and borders, to bring the best possible outcomes to both the local health environment, and more broadly, across Roche globally.

Enablers -

1. Embrace agile ways of working to facilitate the transformation journey and achieve our North Star.
2. Enabler mindset to leverage the internal and external networks to create value and scale impact.
3. Self-managed - Self-management and self-direction - altruistic in supporting the global network to embrace PAM (Purpose. Autonomy and Mastery).