Manager Regulatory Affairs

Abbott; India; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Abbott in Mumbai, India, seeks an experienced Regulatory Affairs professional to lead development of product registration submissions, progress reports, supplements and amendments. You will interact with regulatory authorities to expedite approvals, serve as a regulatory liaison throughout the product lifecycle, and contribute to regulatory strategy and risk management.

The role also involves advising marketing and research teams on manufacturing changes, labeling, compliance, and interpretation

Qualifications

• Strong understanding of how regulatory agencies operate.
• Ability to translate dense legal text into clear briefs for executives and external agencies.
• Experience collaborating with cross-functional teams and external stakeholders.

Responsibilities

• Direct development of product registrations, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agencies to expedite approvals of pending registrations.
• Serves as regulatory liaison throughout the product lifecycle.
• Participates in product plan development, regulatory strategy, risk management, and CMC.
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Advises development and/or marketing teams on manufacturing changes, line extensions, labeling, regulations and interpretations.
• Policy tracking, monitoring regulatory changes and their business impact.
• Impact analysis of regulatory shifts on operations and assets.
• Position development for regulators and external representation.

Skills

Legal acumen

Communication

Cross-functional collaboration

Job description

JOB DESCRIPTION

List the main responsibilities this role regularly performs.

As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Interacts with regulatory agency to expedite approval of pending registration.

Serves as regulatory liaison throughout product lifecycle.

Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).

Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.

Serves as regulatory representative to marketing, research teams and regulatory agencies.

Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

For example you may consider to add :

• Policy Tracking: Monitor new or changing laws, regulatory frameworks, and government proposals.


• Impact Analysis: Assess how regulatory shifts affect business operations, products, or company assets.


• Position Development: Draft official policy interpretations, corporate stances, and defense strategies for regulators.


• External Representation: Speak for the organization in industry associations, trade groups, and public policy forums.

Required Skills

• Legal and Political Acumen: Strong understanding of how legislative bodies and regulatory agencies operate.


• Communication: Ability to translate dense legal text into clear, persuasive briefs for executives and external agencies.


• Skill in collaborating with cross-functional teams and external stakeholders.

The base pay for this position is

N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Regulatory Operations

DIVISION

EPD Established Pharma

LOCATION

India > Mumbai : BKC Building

WORK SHIFT

Standard

TRAVEL

Not specified

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

• Keyboard use (greater or equal to 50% of the workday)