Position Purpose

Regulatory Affairs Manager is responsible for the plan and implementation of product registration, maintaining the approved product licenses and coordinating regulatory Affairs activities in compliance with Health Authority’s regulations and Company’s Standard Operating Procedures (SOPs). She (he) needs to liaise with Pfizer colleagues for supports and guidance.

She (he) should keep good relationship with the regulatory authority, provide knowledge and experience to junior colleagues in solving regulatory related issues and coordinate the cross-function projects.

Be the supervisor or mentor of junior staffs to develop and supervise their assigned projects.

Primary Responsibilities

• Accomplish product registration plan to ensure N DA and Line Extension are approved on agreed timeline

- Participate the development of the registration plans for NDA/LE and implement them timely and effectively with the guidance from Head of Regulatory Affairs.

- Keep good communication with regulatory counterparts on Regulatory Affairs issues to ensure the mutual understanding and obtain timely supports.

- Cooperate with regulatory counterparts to register the new plant through the submission of Plant Master File or Foreign Inspection.

- Closely work with Med/MKTG/PGS to develop new artwork and ensure the success of product launch.

• License maintenance/amendment

- Ensure assigned licenses are renewed in a timely manner.

- Ensure assigned variations are approved in a timely manner.

- Ensure responsible Labeling of on-market products are updated in a timely manner and followed Regulation and Pfizer Policy.

- Ensure assigned projects of manufacturing/packaging site are approved on agreed timeline and closely communicate with PGS to ensure smooth of supply.

- Make sure timely update regulatory information and properly archive regulatory documents.

• Project/System management

- Be a project/system coordinator to ensure project/system are properly monitored and maintained.

- Support RA team for problem shooting coming from systems.

- Work with relevant colleagues to develop Work Instruction to streamline the process and obey Pfizer Policy.

• Relationship management with stakeholders

- Represent the RA role & objectives to both internal & external partners to promote mutual trust and collaborations.

- Cooperate with relevant stakeholders to share information & provide a good understanding on RA-related issues.

- Provide educational, technical assistant to junior RA staffs or other departments if needed.

- Actively attend Association Meeting and get most updated regulatory information.

• Regulatory compliance

- Complete required trainings and comply with relevant standards to ensure compliance to Pfizer Policy.

- Liaise closely with internal stakeholders to ensure on-market products, including labeling, artwork and the finished products, are complied with local regulatory requirements and Pfizer Policy.

- Follow necessary approval procedures in updating Labeling as per local regulatory requirements and Pfizer SOP.

- Ensure the internal regulatory database is up-to-date and meet the requirements according to Pfizer SOP.

• People management

- Be the supervisor/mentor of junior staffs to develop and supervise their assigned projects.

Technical Skill Requirements

A: Technical Competencies :

Knowledge, Interpretation and Application of Regulations and Procedures .

• Through experience, has an integrated understanding of the relevant clinical studies, regulatory documents and/or treatment guideline pertaining to assigned products/TA.
• Is able to independently complete all the assigned complex projects with accuracy and efficiency, such as NDA/LE and propose personal recommendation .
• Effectively discusses the issue of regulatory affairs with project team
• Have the ability to share the team members with what he/she know.

Product and Disease Knowledge

• Utilizes product and disease knowledge to implement assigned projects and provide input in cross-functional activities.
• Always up-to-date with scientific information being communicated on assigned products, critiques data thoroughly and provide informative interpretations/ responses to other groups.
• Actively seeks out information on local competitors and their respective strategies

B: Behavioral Competencies:

Leading and Developing people

• Provides support or assistance to other team members.
• Has ability to be a role model or mentor to others

Planning and Project Management

• Regularly reviews & report progress to superior and other team members.
• Monitors and tracks task progress against evolving project requirements and deadlines.
• Shows awareness of critical task interdependencies and monitors to ensure optimum results.

Communication and strong influencing skills

• Prepares & delivers clear presentations that inform and influence audience as required.
• Summarizes discussion, providing insights on underlying issues which are not obvious to others.
• Ensures that information is shared with the right people at the right time to enable high performance

Problem solving and decision making

• Independently solves problem within defined job responsibilities and expectations.
• Implements solution and follows-up with appropriate action as necessary.
• Acts quickly and decisively in a crisis or other time-sensitive situation

Teamwork and Collaboration

• Facilitates inter-team cooperation through the sharing of information, learning and resources.
• Guides other members as necessary to increase individual and collective team effectiveness.
• Acts in a timely and effective way to address issues of conflict or performance shortfall within the team.

Results orientation

• Seeks out and takes on complex or challenging projects with demanding goals.
• Demonstrates tenacity in pursuing performance goals and achieving the required results.

• Works to ensure that results achieved are durable and repeatable.

Qualifications

Training, Education

Bachelor degree or above, major in Pharmacy or other Life science-related background

Prior Experience Preferred

At least 6-year working experience in Regulatory Affairs.

Good interaction with internal stakeholders (Medical, Marketing, Business Planning, PGS and etc.) and has some experience in working with external stakeholders (IRPMA, Academic and etc. ) and good relationship with HA.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.