Assistant Manager– Regulatory Affairs

Thornton Tomasetti; Mumbai; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Abbott India is seeking a Regulatory Affairs professional to manage global labeling processes, CCDS, and patient information. You will coordinate with SMEs, product leads, and cross-functional teams to ensure compliant labeling documentation and timely updates.

The role requires 5–7 years in pharma regulatory affairs, strong English proficiency, and experience with EU/EM labeling considerations. Location is Mumbai, with standard work hours and global collaboration.

Qualifications

• Bachelor’s degree in Pharmacy or life sciences required.
• Regulatory affairs and global labeling experience in pharma.
• Strong English written and verbal communication skills.
• Experience coordinating with cross-functional teams is a plus.

Responsibilities

• Develops and maintains CCDS and patient information for labeling.
• Collaborates with SMEs and product leads on labeling documentation.
• Reviews labeling guidelines and determines implications for documents.
• Maintains labeling change history and participates in supplier/affiliate support.
• Supports regulatory submissions and renewal activities with RA Ops.

Skills

Regulatory affairs

Global labeling

Pharmaceutical industry experience

English proficiency

Interpersonal skills

Education

Bachelor’s degree in Pharmacy or life sciences

Diploma in Regulatory Affairs preferred

Tools

Microsoft Word

Excel

PowerPoint

Job description

Core Job Responsibilities

With Manager Oversight and Supervision: Global Labeling Portfolio: Develops and maintains EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on the available scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process. Ensures CCDS information is based on Subject Matter Expert (SME) contribution. Organizes and participates in Labeling Sub-Team (LST) meetings, ensuring appropriate actions are followed through. Working with Product Leads, SMEs and cross functional teams ensures appropriate documentation to support label changes (clinical overviews, Module 5 documents, Literature References, etc.) are available to complete labeling project. With oversight, independently completes labeling activities assigned. Assesses and approves change requests for labeling documents. Able to participate and contribute to labeling decisions within cross-functional teams. Supervises labeling compliance of local labeling documents and reconciles deviations with company labeling documents (e.g. CCDS, corresponding patient information). Reviews and evaluates new labeling guidelines/policy (High surveillance countries) and determines implications for company labeling documents/labeling of therapeutic area products. Working with Product Leads and SMEs, develops strategic labeling responses, within cross-functional team at appropriate time.

GRDS Lead / Acting GRDS Lead

Support GRDS Leads/Be a GRDS Lead to support assigned products for all non – cmc documents required by affiliates for regulatory submissions in timely manner.

File Maintenance

Maintains accurate files of labeling change history and associated documents, using the available company electronic systems.

Promotional Material Release

• Reviews and approves promotional materials with respect to CCDS and are compliant. globally applicable guidance and
• Ensures that promotional materials are accurate and compliant to internal codes of conduct, established regulations.

Affiliate Support

Provide labeling support to affiliates including supporting renewals, geo expansions or any license maintenance activity. Educate/guide stakeholders as and when required on labeling procedure with manager’s oversight.

Product Maintenance Activities

• Work with RA Ops to prepare Module 2, Module 4 and 5 & have it ready for affiliate to publish.
• Coordination of RA information to be included in periodic reports – RMP, PSURs, ACOs (for renewals).
• Support renewals with clinical and pre-clinical documentation (EU and EM)
• Provide relevant documents for variations to EU & EM affiliates

Travel: Up to 15% may be required

Job Specifications

Minimum Education: Bachelor’s degree in Pharmacy or life science related subject with appropriate qualification. Diploma in Regulatory Affairs preferred

Minimum Experience / Training Required: Ideally, 5- 7 years work experience, in the pharmaceutical industry Previous experience in Regulatory Affairs, Global Labeling, PV, Medicines Development, Quality or related area(s) Excellent command over spoken and written English is mandatory Strong interpersonal skills to work with global teams is critical Attentive to detail Advanced word processing knowledge and experience with Microsoft Office products (Word, Excel and Power Point)

Preferred Qualifications: Knowledge and hands-on experience with labeling texts for both health professionals and patients.

Key Competencies Requirements

Managerial: N/A

Behavioral: Adaptability Effectively prioritizes short-term (hours/days) work tasks. Responds to learning opportunities. Responds positively to changing situations. Works with others to develop potential alternatives when confronted with problems. Initiative Demonstrates a willingness to learn new aspects of the business (e.g. International regulations; Clinical & CMC; Generics regulations). Proactively seeks feedback from manager and team members and adapts behavior to improve performance. Maintains strong customer focus.

Innovation Identifies / tries different or unique ways (within own project / group) to address work problems or opportunities, and/or reduce costs.

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 participates within team on shared goals

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

Job Family

Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India > Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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