Manager Regulatory Affairs

Abbott; Maharashtra; On-site; INR 1,500,000 - 4,000,000; Full time

Job summary

Abbott is seeking an experienced Regulatory Affairs professional to lead submissions, drive lifecycle management, and liaise with regulatory authorities throughout the product lifecycle. You will coordinate with marketing, R&D, and regulatory teams to ensure compliance and timely approvals for drugs, biologics, and devices.

The role emphasizes translating complex regulations into clear strategies, managing cross-functional teams, and ensuring alignment with global regulatory expectations.

Qualifications

• Deep knowledge of product registration submissions and lifecycle regulatory needs.
• Ability to interact with regulatory agencies to expedite approvals.
• Experience in coordinating with marketing, R&D, and regulatory teams.

Responsibilities

• Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
• Interact with regulatory agencies to expedite approvals.
• Serve as regulatory liaison throughout product lifecycle.
• Participate in product plan development, regulatory strategy, risk management, and CMC.
• Ensure timely approvals of drugs, biologics, or medical devices and continued approvals.
• Advise development and/or marketing teams on manufacturing changes, labeling, and regulatory interpretations.

Skills

Regulatory affairs

Legal 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.