Manager Regulatory Affairs

Abbott Laboratories; Mumbai; On-site; INR 1,500,000 - 1,900,000; Full time

Job summary

Abbott Laboratories in Mumbai seeks a Regulatory Affairs Team Leader to supervise a small team of professionals and drive product registration submissions, progress reports, supplements, amendments, and experience reports. The role acts as regulatory liaison across the product lifecycle and collaborates with marketing, research teams, and regulators to expedite approvals.

With limited supervision, this professional develops regulatory strategy, risk management, CMC considerations, and product

Responsibilities

• Leads a team of professionals within Regulatory Affairs Sub-Function.
• Directs development of product registration submissions and related reports.
• Interacts with regulatory agencies to expedite approvals.

Job description

Location India - Mumbai Category Regulatory Affairs

• Summarize the main purpose of the role Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
  First level manager of a work team that may comprise professionals, technical and/or administrative staff.
  Typically without budget or hire/fire authority.
  Focuses on mentoring, coaching, and coordination.

Main Responsibilities

• List the main responsibilities this role regularly performs. As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals 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.

Location India - Mumbai Category Regulatory Affairs

MAIN PURPOSE OF THE ROLEExperienced professional individual contributor that works under limited supervision.Applies subject matter knowledge in the area of Regulatory Affairs.Requires capacity to app

Location India - Mumbai Category Regulatory Affairs

MAIN PURPOSE OF THE ROLEExperienced professional individual contributor that works under limited supervision.Applies subject matter knowledge in the area of Regulatory Affairs.Requires capacity to app

Location India - Mumbai Category Regulatory Affairs

Primary Job Function:With Manager Support:-1. Product registrations / Submissions-Actively leads product registrations by preparing/ requesting documentation needed for complex filings-Employs proje

Job Id 31162843 LocationIndia - Mumbai Medical surveillance Not Applicable Division EPD Established Pharma Travel Not specified Additional Location Significant work activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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An Equal Opportunity Employer
Abbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.
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We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340or email [e-mail].
Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.