Manager Regulatory Affairs

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

Job summary

Abbott in Mumbai seeks an experienced Regulatory Affairs professional to direct submissions, supplements, and reports, ensuring alignment with regulatory requirements.

You will liaise with regulatory authorities to expedite approvals, act as a regulatory liaison across the product lifecycle, and advise teams on labeling, manufacturing changes, and regulatory interpretations. The role emphasizes cross-functional collaboration and strategic regulatory thinking.

Qualifications

• Experience directing development of product registration submissions and regulatory reports.
• Ability to liaise with regulatory agencies to expedite approvals.
• Serving as regulatory liaison across the product lifecycle.
• Knowledge of regulatory strategy, risk management, and CMC considerations.
• Advising development and marketing teams on regulatory changes, labeling, and interpretations.

Responsibilities

• Direct development of submission documents, progress reports, supplements, and amendments.
• Interact with regulatory agencies to expedite approvals for registrations.
• Serve as regulatory liaison throughout the product lifecycle and cross-functional programs.
• Participate in product plan development, regulatory strategy, risk management, and CMC activities.
• Ensure timely approvals for new drugs, biologics, or medical devices and continued approval of marketed products.
• Advise marketing and development teams on manufacturing changes and regulatory interpretations.

Skills

Regulatory affairs

Policy tracking

Impact analysis

Position development

External representation

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.

Requirements