Senior Regulatory Affairs Executive, Abbott Pharmaceutical (Hanoi) at Abbott

Ho Chi Minh City, Vietnam

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Bachelor's Degree in pharmacy or Registered Pharmacist in Vietnam
More than 3 years relevant experience in regulatory affairs
Knowledge of regulations and standards
Professional skills: Communication, Customer focus, Follow-up, Negotiation, Problem solving and decision making
Behavioral/Leadership skills: Apply Abbott Capabilities Framework
Language skills: Vietnamese/Tiếng Việt, English/Tiếng Anh

Responsibilities

Handle process of registration of new products, maintenance of all approved products in Vietnam and operate marketed products according to local regulations
Reviews and compiles registration dossier for prompt renewal/initial registration
Ensures availability of updated registration documents/samples
Weekly follow up with the authorities as needed
Fast requisition of dossier and check requests
Initiates/monitors/updates Regulatory Report in timely manner
Effects 6-9 months registration plan
Register and compiles registration dossier for promotional material
Ensures all promotional materials are lawfully compliant
Be aware of coming new regulation/change that impact to regulatory or business
Inform head of Department/contacts all change and upcoming new regulations
Implement new regulation properly
Ensures application of special permits and import certificates at MOH
Ensures that all exempt regulated products are MOH verified prior to production use
Ensures that all product labels/package inserts are updated as approved by MOH’s regulation
Keeps registration record updated at all times and promptly submits books and records as per schedule
Ensures prompt coordination with other departments/units such as Sales & Marketing on regulatory and corporate matters
Ensures correctness of received documents vs information submitted
Ensures that all technical documents/dossiers and registration samples are kept in secured place
Maintains proper filing of protocol and other regulatory and clinical related documents
Keeps updated files of MoH Regulations

Skills

Key technologies and capabilities for this role

Regulatory AffairsProduct RegistrationDossier CompilationRegulatory CompliancePromotional Materials RegistrationRegulatory IntelligenceMOH PermitsImport Certificates

Questions & Answers

Common questions about this position

What experience is required for this Senior Regulatory Affairs Executive role?

Candidates need more than 3 years of relevant experience in regulatory affairs, along with knowledge of regulations and standards.

What education is required for this position?

A Bachelor's Degree in pharmacy or being a Registered Pharmacist in Vietnam is required.

What are the key professional skills needed for this role?

Key skills include communication, customer focus, follow-up, negotiation, and problem solving and decision making.

What is the company culture like at Abbott?

Abbott offers career development opportunities, is recognized as a great place to work globally, and supports diversity, working mothers, female executives, and scientists, allowing employees to grow, learn, and be their true selves.

What makes a strong candidate for this regulatory affairs role?

Strong candidates will have over 3 years in regulatory affairs, a pharmacy degree or registration in Vietnam, and skills in communication, negotiation, problem-solving, along with knowledge of Vietnam regulations.

Is this a remote position or does it require office work in Hanoi?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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