Najmiyatun Lailatul Haq Email and Phone Number
A pharmacist with holistic knowledge of the pharmaceutical product life cycle. An adequate understanding of the licensing process within the development, manufacturing, and marketing of drugs and medical devices was acquired from the current job in regulatory affairs of the pharmaceutical industry, and also from the involvement in the top management of the company. Interested in the concept of Health Equity that means everyone having the opportunity to be as healthy as possible, which can be accomplished starting from the applicable policy or regulation. Handled Generasi Bebas Stunting Project (one of Indorelawan yearly programs) in the 6th batch by creating a massive movement in society for stunting prevention.
Pt. Gracia Pharmindo
View- Website:
- gracia.co.id
- Employees:
- 228
-
Regulatory Affairs Assistant ManagerPt. Gracia PharmindoBandung, Id -
Regulatory Affairs Assistant ManagerPt. Gracia Pharmindo Nov 2023 - PresentBandung, West Java, IndonesiaIn charge of overseeing the registration of new products, variations, and renewal of marketing authorization. Despite the challenges involved in registering the products, have been successful in assisting the company, in particular: - Resolved the delayed product registration issue caused by the latest government policy, which resulted in 36 products, obtaining renewal of marketing authorization in one year- Expedited the internal process to prevent the termination of 45% of marketing authorization -
Regulatory Affairs Assistant Manager For New & Import ProductsPt Sanbe Farma Jun 2022 - Nov 2023Bandung, West Java, IndonesiaResponsible for managing the new product registration both local and imported. The leadership skill, strategic thinking, problem solving, decision making, and other related skills were implemented more than the technical skill in these daily tasks:- Managed submission plans for allocated projects that implemented regulatory strategy in the success of achieving Marketing Authorization (MA) of the new products (drugs, biological products, health supplements, import products, and medical devices).- Gave strategic and technical advice to other departments in making a crucial decision for the success of product development based on existing regulations.- Kept on track of the ever-changing regulation and ensured the company was able to adapt toward the updated regulations.- Coordinated with importers for applying import product registration in order to get approval from Indonesian government authority. -
Regulatory Affairs Officer For New & Import ProductsPt Sanbe Farma Aug 2020 - Jun 2022Bandung, West Java, IndonesiaEnsured the product quality met the regulatory requirements and comply with current policies. Started with analyze the dossier of product development and others related data, then proceeded with submission to regulatory agencies in order to get the Marketing Authorization, which reflected with these following details:- Gained 11 marketing authorizations of new products in one year, both local and import.- Achieved new marketing authorization for the flagship product of the company that generated 400 million/month, after it was reformulated due to regulation adjustment.- Presented registration dossier to regulatory agencies (Indonesian FDA & MoH) and conducted any necessary negotiations to obtain or maintain marketing authorization for the products.- Helped the company in avoiding problems caused by inappropriate scientific data from the presented documents and ensured the products to meet government regulations. -
Business Development For Ethical Product PortfolioPt Darya - Varia Laboratoria Oct 2019 - Mar 2020Greater Jakarta Area, IndonesiaAssigned to analyze the new product portfolio and reviewed its feasibility to be continued with the development process, where entering the pharmaceutical market was the final goals of these below duties:- Processed the data to define the potential market of new products.- Created new product concepts to strengthen the General Medicine portfolio in the company by analyzing potential market data as well as considered relevant medical research and related regulations.- Processed relevant market data for more than 100 new product candidates to decide the development status of each candidate. -
Health FacilitatorTransition Team Of West Java Elected Governor Aug 2018 - Sep 2018Bandung Area, West Java, IndonesiaRecruited to handle the forum of various stakeholders which assigend by West Java Elected Governor to create Health Programs acceleration. - Collected health profile data of West Java (Indonesia) for analyzing strategic health issues and arranged strategies to resolve the issue by defining the next 100 days and five years of health programs.- Managed the meeting between the governor team and key stakeholders (health practitioners, government officials, and academicians) to arrange future health programs in West Java (Indonesia).- Assessed health programs from the meeting to be selected as West Java health programs.- Documented and then proposed a strategic document of West Java health program to Development Planning Agency at Sub-National Level.
Najmiyatun Lailatul Haq Skills
Najmiyatun Lailatul Haq Education Details
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Apothecary (Pharmacist) -
Pharmaceutical Science And Technology
Frequently Asked Questions about Najmiyatun Lailatul Haq
What company does Najmiyatun Lailatul Haq work for?
Najmiyatun Lailatul Haq works for Pt. Gracia Pharmindo
What is Najmiyatun Lailatul Haq's role at the current company?
Najmiyatun Lailatul Haq's current role is Regulatory Affairs Assistant Manager.
What schools did Najmiyatun Lailatul Haq attend?
Najmiyatun Lailatul Haq attended Institut Teknologi Bandung, Institut Teknologi Bandung.
What skills is Najmiyatun Lailatul Haq known for?
Najmiyatun Lailatul Haq has skills like Teamwork, Leadership, Management, Public Speaking, Microsoft Office, Microsoft Word, Microsoft Powerpoint, Microsoft Excel, Adobe Photoshop, Interpersonal Communication, Problem Solving, Strategic Planning.
Who are Najmiyatun Lailatul Haq's colleagues?
Najmiyatun Lailatul Haq's colleagues are Thomas Widjanarto, Lintang Dharmayuda, Muhammad Fiqrie, Minar Hutajulu, Hary Fauzia Kamal, Aprian Yogi, Salma Ghassani.
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