Manager - Regulatory Affairs

Abbott Laboratories; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Benefits offered by this job

Innovative benefits

Diversity & Inclusion

Pay transparency

Job summary

Abbott Laboratories in India (Mumbai) seeks a Regulatory Affairs professional to lead product registrations, prepare documentation for filings, and coordinate with regional affiliates. The role requires developing CMC strategies, ensuring regulatory compliance, and interacting with health agencies.

Requires a Bachelor's degree in pharmacy or related field and a minimum of 10 years in Regulatory Affairs, R&D, or manufacturing. Location: Mumbai; category: Regulatory Affairs.

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related subject is required.
• Minimum 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas.

Responsibilities

• Leads product registrations by preparing/re queuing documentation for filings.
• Monitors regulatory activities and timelines; communicates RA positions at meetings.
• Provides CMC regulatory support for due diligence and licensing reviews.
• Develops Regulatory CMC strategies and mitigates risks.
• Interacts with Health Agencies and affiliate teams; maintains compliance.

Skills

Project management

Regulatory knowledge

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in pharmacy or related field

Job description

Location India - Mumbai Category Regulatory Affairs

• Actively leads product registrations by preparing/ requesting documentation needed for complex filings
• Employs project management skills to monitor activities and meet deadlines
• Prepares registration packages for routine filings
• Identifies and collects data needed
• Seeks expert advice and technical support for complex filings
• Prepares responses to deficiency letters

2. Relationships & Cross Functional team work

• Represents Regulatory CMC at relevant project meetings and communicates agreed RA position
• Monitors and communicates actual versus planned regulatory activities and timelines
• Identifies and communicates risks and issues impacting project progression

3. Affiliate Coordination

• Maintains strong working relationships with Regional Product Leads and Affiliate colleagues

4. Compliance across Life-Cycle

• Assess and approves change requests and updates files accordingly
• Maintains awareness of legislation and current developments within specific area of business
• Works to assure products remain in compliance
• Develops Regulatory CMC strategies for assigned products and projects
• Identifies, communicates, and mitigates Regulatory CMC risks

6. Process Improvement

• Identifies opportunities and suggests improvements
• Supports the development of position papers & work aids etc

7. Health Agency Interaction

• Attends Health Agency meetings as appropriate

8. Licensing Reviews

• Provides CMC Regulatory support for due diligence activities

9. Technical competency

• Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products
• Has general knowledge of global and regional regulatory requirements
• Has specialist regulatory knowledge of assigned country or product-class requirements

CORE COMPETENCIES

• Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks
• Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary
• Reacts quickly to solve problems and issues when they arise

Initiative

• Starts to learn new aspects of the business and understand the roles of other functions
• Proactively anticipates, mitigates and avoids problems and issues
• Proactively seeks feedback from manager and team membersand adapts behaviour to improve performance
• Has an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities

Integrity

• Delivers high quality results.
• Meets agreed deadlines.
• Exhibits honesty and presents complete impartial information.
• Displays consistency between words and actions.
• Acknowledges and responds constructively to failures and mistakes.
• Expresses dissatisfaction constructively, without over-reacting.

Teamwork

• Actively interacts with colleagues to drive completion of team and shared goals

LEADERSHIP COMPETENCIES

Set Vision and Strategy

• Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholders

Build Organization and Inspire People

• Mentors junior team members
• Provides training and support on areas of subject matter expertise
• Proactively strengthens own leadership skills and actively uses these skills in day to day work

Drive Results

• Encourages others to complete goals

Make Difficult Decisions

• Interacts with cross-functional and department colleagues to help drive efficient decision-making

Encourage an Open Environment and Knowledge Sharing

• Provides honest, accurate feedback to managers, whether positive or negative
• Not afraid to challenge peers and managers and be challenged
• Openly shares information with peers

Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject

A minimum of 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas

Location India - Mumbai Category Regulatory Affairs

Main Purpose of the RoleSummarize the main purpose of the roleLeads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.First level manager of a work team that ma

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

Job Id 31162946 LocationIndia - Mumbai Medical surveillance Not Applicable Division EPD Established Pharma Travel Not specified Additional Location Significant work activities Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

CREATING POSSIBILITIES

INNOVATIVE BENEFITS

We support our colleagues around the world as they care for themselves and their families with offerings tailored to their unique needs.

DIVERSITY & INCLUSION

We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.

SUSTAINABILITY FOR OUR FUTURE

At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

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JOIN OUR TALENT COMMUNITY

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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.
EEO (ENGLISH) EEO (SPANISH) PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.