【EP/CS】Senior Specialist, Regulatory Affairs at Abbott

Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Associates Degree (± 13 years)
Minimum 1 year of experience

Responsibilities

Direct development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
Interact with regulatory agency to expedite approval of pending registration
Serve as regulatory liaison throughout product lifecycle
Participate in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC)
Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products
Serve as regulatory representative to marketing, research teams and regulatory agencies
Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations

Skills

Key technologies and capabilities for this role

Regulatory AffairsProduct RegistrationRegulatory SubmissionsCMCRegulatory StrategyRisk ManagementMedical DevicesBiologics

Questions & Answers

Common questions about this position

What is the salary for this Senior Specialist role?

This information is not specified in the job description.

Where is this position located?

The position is located in Japan > Tokyo: Hamarikyu Park Side Place 9F, 17F 5-6-10, Tsukiji, Chuo-ku, with no additional locations specified that indicate remote work.

What qualifications are required for this role?

An Associates Degree (approximately 13 years of education) and a minimum of 1 year of experience are required.

What are the main responsibilities in this Regulatory Affairs role?

Responsibilities include directing product registration submissions, interacting with regulatory agencies, serving as a regulatory liaison, participating in product planning and strategy, and advising teams on regulations and changes.

What experience level is needed to succeed in this position?

The role requires a minimum of 1 year of experience and is suited for an experienced professional individual contributor working under limited supervision with well-developed skills in Regulatory Affairs.

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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