Program Manager, Regulatory Affairs, Thailand
5 months ago
**Job Description Summary**: Provides regulatory strategy and direction to the Thailand business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Roles and Responsibilities**:
- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
- Developing in-depth knowledge of country regulation. Uses prior experience and acquired expertise to execute functional policy/strategy.
- Ability to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about regulations and product registration timelines. Explains complex information to others in straightforward situations.
- Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems.
- Develop plan for product registration as per business plan, to ensure market access for our products
- Understands and applies country regulatory requirements and their impacts for submissions
- Ensures compliance with pre
- and post-market product approval requirements
- Support regulatory inspections as required.
- Assess adverse events and field actions for reportability to regulatory authorities and submit post market reporting to regulatory authorities, as per country regulations.
**Required Qualifications**:
- Bachelor's Degree or a minimum of 5 years relevant work experience.
- Ability to communicate effectively in English - reading and good wring skills
- Able to tailor communication path to better meet the needs of the situation.
- Working knowledge of country / region regulations and standards
- Able to identify and monitor for changes to requirements
- Highest integrity in all interactions
**Desired Characteristics**:
- Demonstrated ability to analyze and resolve problems.
- Ability to document, plan, market, and execute programs.
- Ability to work independently in fast-paced environment with little supervision.
- Ability to adapt to constant change and influence positive change effectively.
- Team-oriented and responsive to customer needs.
- Attention to Detail and Results-Oriented.
- Ability to understand technical documentation and execute associated procedures
- Ability to learn regulations effectively
- Applies several sets of requirements together balancing strategy effectively
**Inclusion and Diversity**
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
LI-BA1
LI-ONSITE
LI-HYBRID
**Additional Information**:
**Relocation Assistance Provided**:No
-
Head of Regulatory Affairs Thailand and Lcm
6 months ago
กรุงเทพมหานคร, Thailand Johnson & Johnson Full time**Head of Regulatory Affairs, Thailand and LCM (Innovative Medicine)** **Essential Job Duties and Responsibilities** The role of a Regulatory Affairs Head is a critical and strategic position within an organization. The primary responsibility of a Regulatory Affairs Head is to ensure that the company complies with all relevant laws and regulations...
-
Manager Regulatory Affairs
5 months ago
กรุงเทพมหานคร, Thailand DKSH (Thailand) Limited Full timeAbout DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality...
-
Manager Regulatory Affairs
5 months ago
กรุงเทพมหานคร, Thailand DKSH (Thailand) Limited Full timeAbout DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality...
-
Regulatory Affairs
5 months ago
กรุงเทพมหานคร, Thailand PRTR Full timeOur client is a global pharmaceutical company in Thailand. They're now looking for a Regulatory Affairs to join them. **Responsibilities** - Coordinating closely with suppliers to obtain complete registration documents for faster product registrations in Thailand. - Preparing submissions to the local health authority for new products, license renewal, and...
-
Manager Regulatory Affairs, Gih
2 weeks ago
กรุงเทพมหานคร, Thailand Colgate-Palmolive Full time**Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol,...
-
Regulatory Affairs Assistant Manager
6 months ago
กรุงเทพมหานคร, Thailand Healthcare (OHQ) Full time**Job Title**:Regulatory Affairs Assistant Manager **Location**:Krung Thep Maha Nakhon Bangkok, Thailand**Employment Type**:Permanent**About OMRON** - Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in Industrial...
-
Regulatory Affairs Manager
6 months ago
กรุงเทพมหานคร, Thailand Elanco Full timeEducation : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...
-
Regulatory Affairs Manager
2 months ago
กรุงเทพมหานคร, Thailand Vinarco Full timeJob Description: **Location**: Pathumwan, Bangkok **Type of Hiring**: Permanent **Responsibilities**: - Independently manage routine regulatory activities for the assigned product portfolio. - Oversee the registration of new products and line extensions according to the planned schedule to ensure timely product launches. - Handle the renewal of product...
-
Manager Regulatory Affairs Own Brands Healthcare
5 months ago
กรุงเทพมหานคร, Thailand DKSH (Thailand) Limited Full timeAbout DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality...
-
Manager Regulatory Affairs Own Brands Healthcare
5 months ago
กรุงเทพมหานคร, Thailand DKSH (Thailand) Limited Full timeAbout DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality...
-
Manager, Regulatory Affairs
5 months ago
กรุงเทพมหานคร, Thailand Edwards Lifesciences Full time**Key Responsibilities**: - Plan registration and labeling strategies and activities within agreed timeline in order to deliver licenses and to ensure regulatory compliance. - Identify and evaluate registration and labeling, and build process improvements and course correction/course alignment opportunities. - Provide direction and guidance to other team...
-
Assistant Manager Regulatory Affairs
6 months ago
กรุงเทพมหานคร, Thailand DKSH (Thailand) Limited Full timeAbout DKSH DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology. Delivering life-saving drugs to hospitals, bringing high-quality...
-
Expert, Regulatory Affairs Hnc Thailand
3 weeks ago
กรุงเทพมหานคร, Thailand DSM Full time**Job title** - Expert, Regulatory Affairs HNC Thailand **Location** - Bangkok, Thailand **Job model **- 2-year contract At dsm-firmenich, people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace. **Your key responsibilities** - Develop and implement regulatory strategies for the...
-
Regulatory Affairs Manager Hnc
6 months ago
กรุงเทพมหานคร, Thailand DSM-Firmenich Full time**Job title** - Regulatory Affairs Manager, HNC **Job model **- Hybrid To ensure that dsm-firmenich products comply with the diverse and complex regulations in the region, the Regulatory Affairs Manager will advise / define the internal requirements for new products to ensure efficient market clearances and compliance within the Pharma segment are...
-
Head of Regulatory Affairs Thailand
7 months ago
กรุงเทพมหานคร, Thailand Pfizer Full timeJob Summary Regulatory Sciences Team Lead is responsible for providing leadership and strategic direction of PBG products in country, management of Regulatory Sciences team in country, to interface with other function leads (e.g. GCMC, GLS, SOS, PGS, Commercial, Medical) to ensure collaborative connectivity with these key stakeholders, and a more focused...
-
Regulatory Affairs
6 months ago
กรุงเทพมหานคร, Thailand Kensington Associates Recruitment Full time**Regulatory Affairs - Supplements**: Bangkok Full Time and Permanent Nutrition 120,000 - 160,000 02 634 8884 **Regulatory Affairs - Supplements** - Being responsible for the registration of supplement products with the Thai FDA and other government agencies (including regulations of product registration, product classification, packaging and product...
-
Government Affairs Manager-corporate Management
5 months ago
กรุงเทพมหานคร, Thailand Lazada (Thailand) Co., Ltd. Full timeAs the Government Affairs Manager at Lazada, you will spearhead the management of relationships with government officials, policymakers and regulatory bodies. Your primary mandate will involve shaping public policy and championing the interests of our platform within governmental spheres. This pivotal role demands a profound understanding of regulatory...
-
Regulatory and Stewardship Assistant
2 months ago
กรุงเทพมหานคร, Thailand Corteva Full time**Description**:** Regulatory and Stewardship Affairs** - Support the execution of Regulatory & Stewardship programs as aligned with country regulatory manager. - Build a transparent, bold and countable communication on the regulatory information, impact on the business and implications. **Regulatory Compliance and Product Stewardship** - Support reviews...
-
Regulatory Affairs Manager
5 months ago
กรุงเทพมหานคร, Thailand L'Oreal Full time**Who are we?** ***At L’Oréal, there is never a dull day, the beauty lies in the freedom to go beyond with our empowering entrepreneurial culture. We take pride in developing young talents who have the passion and ambition to make an impact in the **beauty industry**. **Join us on our mission to: Create the beauty that moves the world.** ***Watch our...
-
Regulatory Affairs Manager
2 months ago
กรุงเทพมหานคร, Thailand Organon Full time**The Position** The RAaPV Senior Specialist is responsible for all aspects of regulatory submissions in the assigned markets. Critical to this role is to combine knowledge of scientific, and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on...