Regulatory Compliance at Abbott

Mumbai, Maharashtra, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Medical DevicesIndustries

Requirements

Candidates must possess a B.Pharm, M.Pharm, or M.Sc. degree in a pharmaceutical or life sciences discipline. A minimum of 8-12 years of experience in Regulatory Affairs, preferably within a multinational or leading Indian pharmaceutical company, is required. Familiarity with regulatory platforms such as SUGAM, ONDLS, NSWS, and SolTRAQs is desirable. Prior experience in Quality Assurance is also considered a plus.

Responsibilities

The Regulatory Compliance professional will lead and manage all regulatory affairs activities for the manufacturing site, ensuring timely regulatory submissions and compliance with all applicable regulations. Key responsibilities include preparing and submitting various applications and licenses to State FDA, liaising with health authorities, handling product complaints, providing regulatory support for product internalization and externalization, and maintaining regulatory databases. The role also involves reviewing and tracking the regulatory impact of quality documents, approving site change controls, obtaining tender certificates, supporting the preparation and revision of Regulatory SOPs, and delivering training on GMP and regulatory updates.

Skills

Regulatory Affairs

Regulatory Submissions

Compliance

D&C Act

NDPS Act

GMP

GLP

CMC Documentation

Change Control

Quality Assurance

Product Registration

Health Authority Liaison

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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