Assistant Manager -Regulatory Affairs

Abbott; India; On-site; INR 350,000 - 650,000; Full time

Job summary

Abbott in Mumbai, India seeks an experienced Regulatory Operations professional to lead global labeling activities. You will develop CCDS and core patient information, coordinate cross‑functional teams, and ensure compliant labeling across affiliates and renewals.

Working with Product Leads and SMEs, you will review guidelines, prepare documentation, and supervise labeling changes with oversight to ensure regulatory submissions are timely and compliant.

Qualifications

• Bachelor’s degree in Pharmacy or life science; Diploma in Regulatory Affairs preferred.
• 5–7 years of experience in pharmaceutical regulatory affairs or related area.
• Excellent command of English (spoken and written).
• Strong interpersonal skills to work with global teams; attention to detail.
• Proficient with MS Office (Word, Excel, PowerPoint).

Responsibilities

• Develops and maintains CCDS and Master Package Leaflet based on scientific knowledge and labeling requirements.
• Organizes Labeling Sub-Team meetings and ensures actions are followed.
• Documents label changes with SME input and cross-functional support.
• Independently completes labeling activities and assesses change requests.
• Supervises labeling compliance and reconciles deviations with company labeling documents.
• Reviews new labeling guidelines and determines implications for labeling of products.
• Develops strategic labeling responses with cross-functional teams.
• Supports affiliate labeling across renewals and geo expansions.
• Educates stakeholders on labeling procedures under manager oversight.
• Coordinates Module 2, 4 and 5 information for affiliate publication; supports renewals with clinical docs.

Skills

Interpersonal skills

English proficiency

Detail oriented

Cross functional collaboration

Education

Bachelor’s degree in Pharmacy or Life Science

Diploma in Regulatory Affairs preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

JOB DESCRIPTION

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 (list is for reference and not limited)

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

Travel

Up to 15% may be required

JOB SPECIFICATIONS

Skill, Education, Experience

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 industryPrevious experience in Regulatory Affairs, Global Labeling, PV, Medicines Development, Quality or related area(s)Excellent command over spoken and written English is mandatoryStrong interpersonal skills to work with global teams is criticalAttentive to detailAdvanced 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