＜感染症領域＞Regulatory Affairs Manager at Abbott

Shinjuku-ku, Tokyo, Japan

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Infectious DiseasesIndustries

Requirements

Bachelor's degree in pharmacy, chemistry, or biology, or equivalent practical experience and knowledge
Experience in performing tasks using English documents
At least 1 year of experience handling numerical data (preferably in the pharmaceutical industry in research & development, manufacturing, or quality assurance)
Communication skills: Ability to engage in smooth communication with internal and external stakeholders based on trust
Industry knowledge and judgment: Knowledge of pharmaceutical regulations, industry norms, product knowledge, and quality systems, with the ability to make balanced regulatory judgments
English proficiency: Ability to communicate appropriately with overseas manufacturers and correctly understand English documents (guideline: TOEIC score 650+)
Collaboration skills: Ability to cooperate with members in own department and cross-functional teams, with coordination and leadership
Experience with FD applications or online applications
Required training: Pharmaceuticals and Medical Devices Law (薬機法) and related notifications, QMS Ministerial Ordinance and related notifications, and other training specified in the education/training system procedures

Responsibilities

Develop application and launch strategies for new products to obtain timely regulatory approval and insurance listing
Evaluate impacts of changes to existing products and perform corresponding regulatory actions
Maintain business operations, licenses, etc., and conduct activities to ensure compliance with the Pharmaceuticals and Medical Devices Law (薬機法)
Guide and develop team members
Plan and execute regulatory approval applications, QMS conformity inspections, and insurance applicability to authorities
Directly negotiate, coordinate, and discuss with regulatory authorities and other companies regarding regulatory approvals and insurance applicability
Review advertisements and customer letters to ensure compliance with the Pharmaceuticals and Medical Devices Law (薬機法)
Strategically participate in industry association activities and appropriately gather information
Perform personnel management, budget management, and work environment management
Implement talent development and education plans
Perform other tasks instructed by superiors

Skills

Key technologies and capabilities for this role

Regulatory AffairsDrug ApprovalQMS CompliancePMDA NegotiationsInsurance ReimbursementPharmaceutical RegulationsStakeholder CommunicationTeam LeadershipEnglish ProficiencyBudget ManagementIndustry Knowledge

Questions & Answers

Common questions about this position

What is the base pay for this Regulatory Affairs Manager position?

The base pay for this position is listed as N/A. In specific locations, the pay range may vary from the range posted.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What education and experience are required for this role?

A bachelor's degree in pharmacy, chemistry, or biology or equivalent practical experience and knowledge is required. Experience handling tasks using English documents and at least 1 year of experience handling numerical data (preferably in pharmaceutical industry R&D, production, or quality assurance) are also needed.

What key competencies are needed for the Regulatory Affairs Manager role?

Required competencies include communication skills for smooth interactions with stakeholders, industry knowledge and judgment on regulations, English proficiency (TOEIC 650+), collaboration and leadership in cross-functional teams, and experience with FD applications or online submissions.

What does the role involve in terms of team management?

The role includes guiding and developing team members, personnel management, budget management, work environment management, and executing talent development and training plans.

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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