WEST ASEAN NEWSLETTER Issue 30 November 2022

West ASEAN Regulatory Highlights 2022

Achievements/Best Practices in 2022

People Insights: Career Growth Journey

Recap of submissions and approvals by West ASEAN teams in 2022

Celebrating the achievements of each West ASEAN team over the past year

Learn more about our West ASEAN colleagues’ inspiring growth experiences

introduction Inside this Issue Special message from our West ASEAN Cluster Lead People Insights West ASEAN Regulatory Highlights 2022 Achievements/Best Practices in 2022 Welcoming New Members Joy Moments: "You and Yours Essentials" Bonus page (Read on to find out!)

editor's note Hi everyone!

Welcome to the 2nd issue of the West ASEAN newsletter. "Growth" is our main theme for this year. As we recapped on 2022 and highlight our achievements as cluster, we also aim to bring you more stories that matter to you. You can read about our colleagues' experiences in developing their careers under the "People Insights" page and find out what are the essentials that have been keeping our colleagues going for the past year under our "Joy Moments: You and Your Essentials" page. We hope that you will enjoy this issue of the newsletter! Thank you for your incredible contributions in 2022 and we wish that you have a great 2023 ahead.

Editors : Sulistya Ningsih Lim Zhihao Sponsor: Kang Tse Siang Chow Wan Lee R.Iin Nurhayati

Contributors : Chow Wan Lee Nur Fatimah Safri Anggita Putri Edwita Ng Su Sen

special message

Traveling Experience Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

PEOPLE INSIGHTS G R O W T H

J O U R N E Y

CHOW WAN LEE HEAD RA, MY

Growth journey as GRPI secondee In Pfizer, there are many opportunities available to help us broaden our experiences and develop new skills. We just need to take the first step, to seek the opportunity. My journey as GRPI secondee started in September 2021. Severine from RRHS and I were given the opportunity to join the GRPI secondment on a part-time basis (20%).

Excellence The secondment to GRPI provides me the opportunity to learn the development of the Asia Regulatory Policy Insights Report with reference to the GRA-I Asia Strategic Advocacy Plan (SAP) for 2021 to 2023. The GRA-I Asia SAP is a high-level roadmap to achieve Pfizer’s regulatory policy objectives. This exercise supported me to strategize the development of regulatory policy goal in my country to support the regulatory policy priority and regulatory environment shaping. To ensure Asia colleagues are well connected to the policy development in US, we also organized GRPI -GRA-I Asia Interactive Regulatory Policy Sharing Session where we discussed the PDUFA VII Agreement. I had the opportunity to work with great leaders to plan the agenda and coordinate the session.

PEOPLE INSIGHTS G R O W T H

J O U R N E Y

Courage & Equity I experienced courage and equity working

for Malaysia BoH. In addition to external

on regulatory advocacy plan for Real World

engagement, I also had the opportunity to

Evidence (RWE). RWE is an important topic

team up with Sin Yee (RRHS) to share RWE

globally and increasing importance for

regulatory

Pfizer and Asia region.​ I had the opportunity

region and Pfizer’s RWE experience for

to work closely with RWE CoE team and

Ibrance male breast cancer indication with

GRPI’s RWE SMEs to organize RWE webinar

ILG team.

policy

development

in

Asia

Joy I learn new ideas to engage with my team

In short, GRPI secondment has been an

during GRPI team meetings. I adopted the

enriching experience for me. I commit to

concept of JOY session from GRPI team to

continue

my Malaysia RA team. Now we understand

knowledge

each other better and we do look forward

environment shaping in Asia.

to our monthly team meeting for the team bonding session.

learning to

and

support

applying the

my

regulatory

PEOPLE INSIGHTS G R O W T H

J O U R N E Y

NUR FATIMAH A.S. RA MANAGER, MY

Temporary Medical (Nov 2013) Medical Admin (Dec 2013) Assoc. RA (Feb 2014) RA Executive (Sep 2014) Medical Quality Oversight Liaison secondment (Nov 2017 - Feb 2018) Senior RA Executive (Apr 2018) RA Manager (Oct 2019) My journey in Pfizer started in November 2013 as one month contractor working for the Medical Team to do hard copy data checking for the local CSR activity. I was out of work at that time, and coming from a family of HCPs, I grabbed the opportunity even if it’s just for a short stint because it’s Pfizer! From here on, one after another opportunity came about and brings me to where I am today.

I DARE myself to try. Honestly, I was scared and doubtful of myself before starting each role – can I really do it? But once I gained my momentum, I had my full gear on. But as life cycles goes, there will be a point where I want to give up – I feel like I was way lag behind. I am not a person who easily SPEAKS UP about my feelings, but once I do so, I know it’s not as bad at all. If it’s not because of the SUPPORT and TRUST I got, I would probably not be here today. One other thing that always pulls me back together is a reminder to myself, why I love what I’m doing. It’s always about the people that will benefit from the work that I do. People will not know me, but I know I am part of the betterment of their health journey. Never stop yourself from trying and accepting challenges, yet you NEED TO KNOW WHAT YOU WANT – where to draw a line and when to cross it. You may fail, but that failure is the best lesson you will ever get to make you do better.

PEOPLE INSIGHTS G R O W T H

J O U R N E Y

ANGGITA PUTRI E. SENIOR RA, ID

I joined Pfizer in July 2019 as Senior Regulatory Affairs Associate. I spent my initial 1.5 years swimming and diving deep into the role. In 2021, I felt comfortable to add new flavor to my daily worklife by joining Indonesia Diversity, Equity and Inclusion (DEI) council. I am leading a workstream focusing on diverse talent engagement to improve women participation at workplace and support their

professional

improvement.

This

was

initially

intended as an extracurricular for me but it turned out to be one that influences my development. Joining Indonesia DEI council provides not only a place where I can work with colleagues outside GRA-I with different ways of working but also an opportunity to improve my leadership skill. The activities have also provided me an opportunity to engage with Indonesia’s Leadership Team (LT) and to learn from them.

In

March

2022

I

joined

Portfolio

Management

Champion

Community

(PMCC)

representing Asia PCO. My initial interest in joining PMCC comes my intention to get more above-country exposure which allows me to learn various GRA-I processes while contributing by being the voice of the region. This is aligned with my career aspiration to be a global strategist. By joining PMCC, not only do I have better understanding about GRA-I processes but also a safe space to practice speaking up, to apply critical thinking and to understand areas of work within Asia and other regions that I normally don’t have exposure to as a PCO. One thing I would like to highlight and encourage the rest of my colleagues from my growth journey is to be honest about WHAT YOU WANT and WHAT YOU NEED. We don’t have forever to achieve things, which is why being honest with yourself will help.

WEST ASEAN REGULATORY

HIGHLIGHT FOR 2022

Read More>

SINGAPORE 1. Apexxnar NDA submission in Singapore on 18-May-2022 This is a particularly meaningful submission for Pfizer Singapore, as this submission brought the filing plans for this important franchise well close to the filing timepoints in major reference agencies and is one of the first to file in Asia. Importantly, this is the first Pfizer Singapore’s first submission of a biological product via the verification evaluation route, and it was achieved through a series of advocacy and negotiation with local BOH on behalf of the industry to expand the scope of verification evaluation route to include biological products. As a result of Pfizer’s advocacy, the Biological products are now officially scoped within Verification evaluation route . Following the recent news of an earlier than expected approval of Apexxnar in the EU by the EMA, the team worked closely to further shave 2 months off the initial planned submission timeline (Jul 2022) in Singapore. 2. Nurtec NDA submission in Singapore on 25-Jul-2022 Singapore was the first country in EM Asia to file the new drug application for Nurtec. 3. Singapore’s Comirnaty Journey: 10mcg Tris Formulation for 5 to 12yo (Wildtype) - market authorization received on 10-Dec-2021. Leveraging on the interim authorization (PSAR) submission, market authorization was received within 10 days from NDA submission. 3mcg Tris Formulation (Wildtype) for 6 months to 12yo - interim authorization received on 11-Oct-2022. Evaluation took around 5.5 weeks from the first roll submitted on 01-Sep2022, making Singapore the first in EM to receive regulatory approval to allow import and utilization of the BA.4-5 bivalent vaccine 10mcg Tris Formulation (Wildtype) booster for 5 to