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

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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. HEAD RA, MY G R O W T H J O U R N E Y PEOPLEINSIGHTS CHOW WAN LEE

Courage & Equity I experienced courage and equity working on regulatory advocacy plan for Real World Evidence (RWE). RWE is an important topic globally and increasing importance for Pfizer and Asia region. I had the opportunity to work closely with RWE CoE team and GRPI’s RWE SMEs to organize RWE webinar G R O W T H J O U R N E Y PEOPLEINSIGHTS Joy I learn new ideas to engage with my team during GRPI team meetings. I adopted the concept of JOY session from GRPI team to my Malaysia RA team. Now we understand each other better and we do look forward to our monthly team meeting for the team bonding session. for Malaysia BoH. In addition to external engagement, I also had the opportunity to team up with Sin Yee (RRHS) to share RWE regulatory policy development in Asia region and Pfizer’s RWE experience for Ibrance male breast cancer indication with ILG team. In short, GRPI secondment has been an enriching experience for me. I commit to continue learning and applying my knowledge to support the regulatory environment shaping in Asia.

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. RA MANAGER, MY G R O W T H J O U R N E Y PEOPLEINSIGHTS NUR FATIMAH A.S.

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. SENIOR RA, ID G R O W T H J O U R N E Y PEOPLEINSIGHTS ANGGITA PUTRI E.

WEST ASEAN REGULATORY

HIGHLIGHT FOR 2022

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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. 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

2. Best Practices: BoH’s request to redefine DS Regulatory Starting Materials (RSM) One of the biggest challenges that the Malaysia RA team faced in the past year was Malaysia BoH’s request to redefine the proposed RSM for various NDAs and approved drugs as they said the molecules are complex. For over a year now, there have been a series of rejections, back-andforth communication with the BoH at almost all levels because both parties want to stand on their own ground, to the point that the team almost gave up on one of the applications. With full support from all stakeholders, the Malaysia RA team recently managed to obtain prescreening approval for Staquis NDA after one and a half year. There are ongoing BoH requests to redefine the RSM for multiple approved drugs and the team will continue to work towards overcoming these challenges. MALAYSIA & BRUNEI 1. E-Labeling Initiatives Pfizer leading the conversation in the HA and Joint Industries E-labeling Task Force meeting on 30th May 2022. Pfizer representing joint industries (PhAMA, MOPI and MAPS) presented the e-labeling pilot project proposal for NPRA and PSP.

2. EUA Paxlovid approval obtained in July 2022 EUA requirements in Indonesia are not as flexible as other countries. Close-knitted collaboration among cross-functional teams was critical in overcoming the hurdles during our application process. . INDONESIA 1. Accelerated approval of Zavicefta major variation Obtained accelerated approval of Zavicefta major variation on new API source of ACSD site 5 months ahead of expected approval timeline to ensure supply continuity. 3. Nurtec NDA submitted ahead of plan in September 2022 Support from various cross-functional teams allowed us to push for an earlier submission ahead of time. It was the second time that the Indonesia team used the Asia Core Dossier for NDA submission. 4. Leading the conversation for e-labeling initiatives in Indonesia Successfully obtained BoH’s approval on 3 November 2022 to implement QR codes that encode the PI on the outer cartons for Eliquis 2.5 mg and 5 mg film-coated tablet as part of a locally initiated e-labeling pilot project in Indonesia. In parallel, we are leading e-labeling discussion in local trade association (IPMG) with BoH for E-labeling Guideline in Indonesia and have already submitted the official proposal for pilot project. IPMG is also actively working with APAC e-labeling EWG. The main target is to get endorsement from BoH for pilot project elabeling guidelines at the end of this year such that pharmaceutical companies in Indonesia can start to implement e-labeling without physical leaflet in 2023. 5. First placed winner for GRA-I Asia Got Talent contest in VARRM 2022

WELCOMEABOARD H E L L O T O O U R N E W E M P L O Y E E S Birthday: 19 Oct 1994 Hobby: Listening to music and watching movies Hi everyone, Zhihao from Singapore team here! I have been working at Khoo Teck Puat Hospital as a registered pharmacist for two years before joining Pfizer. This is my first job in a pharmaceutical company, and I am excited to be given this opportunity to join Pfizer. I am very thankful that Pfizer has a great working environment with many helpful and approachable colleagues. Hope to meet all of you some day! LIM ZHIHAO Birthday: 13 Jan 1994 Hobby: Listening to music Hi everyone, I am William, a Registered Pharmacist with Pharmacy Board of Malaysia. I graduated with Bachelor of Pharmacy (Hons) from UCSI University Malaysia. After completing the one-year compulsory service as Provisionally Registered Pharmacist at Klinik Kesihatan Puchong, I worked as Branch Supervisor in I Pharmacy where I was responsible to manage medications dispensing, patient counselling, stock inventory and online sales platform. Subsequently, I worked as Regulatory Affairs/New Product Development Executive at VitaHealth Malaysia where I managed product registrations and renewals for Malaysia, Thailand, Brunei, Singapore and Vietnam. Apart from work, I am an audiophile who likes to listen to music and walk my dog during my free time. WILLIAM CHOO

WELCOMEABOARD H E L L O T O O U R N E W E M P L O Y E E S IDA FITRIYANI Birthday: 18 February 1996 Hobby: Listening to music, watching movies, and traveling Hi! I am Ida Fitriyani. Such a wonderful opportunity to join Pfizer! Especially regulatory team. This is the position which I expected before. The first time I was here, I was really amazed with the cool open space workplace and the views outside. All colleagues are kind, heartwarming, and welcome to answer everything I ask. Thank you, Bu Iin and Team, for the kindhearted welcoming. This is one of the privileges, time flexibility. I also can improve my communication skills whether local and global. I will do the best for supporting regulatory in Indonesia. This is going to be my challenging journey, something brighter for career pathway. Birthday: 19 Jan 1998 Hobby: Reading and hiking I joined Pfizer in November 2022. I was previously working in Novartis Singapore for the past year as a regulatory affairs specialist, handling the established medicines and ophthalmology portfolios. I look forward to opportunities to get to work and learn with everyone! ABIGAIL TAN

Kimberly, MY (Third from right): My support system ❤ Abigail, SG (First from right): Family and food are definitely essentials! Si Jia, SG (Second from left): This pair of Adidas running shoes has been my essential from the start of Covid (probably time to replace it). One good outcome of Covid was that I went back to running during the Circuit Breaker and hopefully I will be able to continue with this habit! Zamala, MY: Family….where life begin and love never ends. Dian, ID: My family gives me the wings to fly above the darkness and find the light Kenny, SG: Happy family is a essential for me to carry on everyday Gita, ID: Handphone is my essential. I do many things: play games (definitely!), watch movies and series, listen to music & podcasts, read articles and e-books, shop, and pay bills, prepare travels, and many others. This also supports my work at Pfizer. Most importantly, I use it to stay connected with my support system, who's miles away from Jakarta Ying Ying, MY: My essential is yummy food, an example is dessert shown in my photo. Dessert makes me happy and is a form of support system to me whenever I am stressed or sad, it is also best to eat yummy food with good company William, MY: Hi everyone, I am William from Malaysia, hair clipper is one of my essentials. Especially for the past 2 years, it has been helping me to keep my hair neat for me to look presentable. Kang Tse Siag, SG: Special year end birthday celebration for my wife and kid

Coffee = My Daily Happy Pill zhihao, SG: Need my daily cup of coffee to get me through the day. My favourite coffee drink being Yuan Yang from Yakun which is a mix of coffee and tea! Su Sen, SG: My little boy Mani is turning 1 yr old this month. Such a joy to have him in my life. Fatimah, MY: Most of the things that I do even if its work related is because of my family, my kids especially, although they drive me up the wall all the times! iin, ID: My Mom is my superhero, she is always beside me, accompanying my struggle during college time until get a job outside of the hometown. This photo was taken when my mom and I visited Bali, as the first gift from me after I got my first bonus. This is her first experienced to go outside by airplane

DOWN "Happy Holiday everyone! It's been a busy year, but we wouldn't have it any other way" GET TO KNOW YOUR TEAM! 3. Blue is her favorite color. The name of her child is the same as her favorite color. Who is she? 5. She used to skip Additional Mathematics classes and had never passed this subject in high school. However, she managed to score the highest grade in the final national exam. Who is she? 7. He is most afraid of having an angry wife and if he has 48 hours a day, he’d spend it with extra sleep time. Who is he? 9. After giving birth, her weight increased by 20 kg and now she is trying to lose it. Who is she? 10. There are several cat owners in the Singapore RA team. Other than Tse Siang and Su Sen, do you know who is also a cat owner? ACROSS 1. She is a gamer and she has been playing Cookie Run since 2015. Who is she? 2. Football is her favorite sport but she does not know how to play it. Who is she? 4. She is afraid of repetitive pattern of tiny holes (Trypophobia). Who is she? 6. One of our colleagues had a baby boy in March this year! Who is she? 8. It is difficult to juggle between work and studying but one of our colleagues completed her Master of Public Health degree program in late 2021 and had her convocation this past year. Who is she? 1.Gita 2. Ida 3. Dian 4.Kimberly 5. Fatimah 6. Serene 7.Cheok Weng 8. Wan Lee 9.Nining 10.Kenny