Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi) at Abbott

Hanoi, Hanoi, Vietnam

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

7 years’ experience in Regulatory, prefer pharmaceutical MNC. Experience in leading a team of RA professionals
Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam
Ability to handle high levels of pressure and critical decision-making
Good leadership, interpersonal, teambuilding, and problem-solving skills
Skilled communicator with well-developed verbal, written and presentation ability
Strategic

Responsibilities

Plan, direct, and monitor regulatory affairs to ensure the organization has necessary permits, licenses, certificates, authorizations, and approvals for current and future business activities
Maintain local SOPs and Regulatory policies and provide support to Abbott Healthcare's business, ensuring compliance with current Vietnam regulatory requirements
Serve as primary contact with DAV, MOH, and relevant Authorities: Liaise with government to ensure regulatory compliance and establish/maintain positive relationships with government agencies and other regulatory authorities
Liaise with functional managers to understand short to medium-term business goals (e.g., introducing new products/services, entering new markets) and develop plans, cost estimates, schedules for acquiring necessary permits/approvals
Own ultimate accountability for the function and provide advice/recommendations on company regulatory compliance
Ensure regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations/laws and standards
Assure all audits so that organization and government standards on products/processes are met
Consult on an ongoing basis on related issues with the management team
Supervise the registration of marketed products
Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution, and sale of Abbott products
Provide consultation to Operations, QA, and Commercial teams on suitability/acceptability of new product submissions supporting documents as per Vietnam regulatory standards
Provide regulatory input and support for marketing plans, product launches, and other cross-functional activities
Review and provide input/approval on promotional materials, product information, and labels for regulatory compliance
Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with Abbott global SOPs & policies and DAV/VN MOH requirements
Support employees in implementing their growth plans; develop and maintain succession plans and address future staffing issues proactively
Manage team’s development throughout the path to achieve goals
Ensure team activities comply with Company Business Code of Conduct and all local applicable laws within scope of function responsibility
Handle special projects as needed by Management team

Skills

Regulatory Affairs

Regulatory Compliance

SOP Management

Government Liaison

Vietnam MOH

DAV

Permits and Licenses

Product Approvals

Regulatory Strategy

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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