Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi) at Abbott

Hanoi, Hanoi, Vietnam

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

>7 years’ experience in Regulatory Affairs, preferably in a pharmaceutical multinational company (MNC)
Experience leading a team of Regulatory Affairs 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 abilities
Strategic skills

Responsibilities

Plan, direct, and monitor regulatory affairs to ensure the organization obtains necessary permits, licenses, certificates, authorizations, and approvals for current and future business activities
Maintain local SOPs and Regulatory policies, providing support to Abbott Healthcare’s business to ensure compliance with current Vietnam regulatory requirements
Act 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 regulatory authorities
Liaise with functional managers to understand short- to medium-term business goals (e.g., new products, services, processes, market entry) and develop plans, cost estimates, and schedules for acquiring necessary permits/approvals
Own ultimate accountability for the function, providing advice and recommendations on company regulatory compliance
Ensure regulatory affairs activities are conducted accurately, ethically, and in accordance with relevant regulations, laws, and standards
Assure all audits meet organization and government standards on products/processes
Consult with management team on related issues on an ongoing basis
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 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 development 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 the management team

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory ComplianceSOP ManagementGovernment LiaisonDAV InteractionMOH RegulationsVietnam Regulatory RequirementsPermit AcquisitionLicense ManagementStakeholder Relationship Management

Questions & Answers

Common questions about this position

What is the employment type for this Regulatory Affairs Manager position?

The position is full-time employment.

Is this Regulatory Affairs Manager role remote or office-based?

This information is not specified in the job description.

What are the main responsibilities for this role?

Key responsibilities include planning and monitoring regulatory affairs for permits and approvals, liaising with DAV, MOH and authorities, supervising product registrations, supporting QA, Manufacturing and Marketing, and maintaining local SOPs and policies.

What is the company culture like at Abbott?

Abbott offers work that matters with opportunities to grow, learn, care for yourself and family, and be your true self; it's recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for the Regulatory Affairs Manager role?

Strong candidates will have experience in regulatory affairs, particularly in Vietnam with DAV and MOH, ability to liaise with authorities, manage product registrations, ensure compliance, and support cross-functional teams.

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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