Manager Regulatory Affairs

Abbott Laboratories; Mumbai; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Abbott Laboratories in Mumbai seeks an experienced Regulatory Affairs professional to direct product registration submissions, progress reports and amendments throughout the lifecycle.

You will liaise with regulators, guide cross-functional teams, and help ensure timely approvals for drugs, biologics or devices. This role emphasizes policy tracking and external representation to industry groups.

Qualifications

• Strong understanding of how legislative bodies and regulatory agencies operate.
• 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.

Responsibilities

• Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
• Interact with regulatory agencies to expedite approval of pending registrations.
• Serve as regulatory liaison throughout the product lifecycle.
• Participate in product plan development and implementation, regulatory strategy, risk management, 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.
• 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.

Skills

Legal and Political Acumen

Communication

Cross-functional Collaboration

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.