Specialist - Product information Specialist

Mployee.me; Mumbai; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Mployee.me in Mumbai is seeking a Product Information Specialist to support Regulatory Affairs in preparing high-quality PI documents such as CCDS, SmPCs, PLs, and labeling. The role involves close collaboration with Regulatory Affairs, Pharmacovigilance, and Medical Affairs to ensure accuracy and regulatory compliance.

You will manage document control, perform QC, and coordinate PI-related processes across global teams, while staying aligned with internal SOPs and templates.

Qualifications

• Bachelor's or Master's in life sciences, B.Pharm/M.Pharm or health-related field.
• Strong writing skills for SmPCs, PLs and regulatory docs.
• Ability to simplify complex medical terminology for wide audiences.

Responsibilities

• Coordinate creation of PI documents (PI, CCDS, SmPCs, PLs, labels) with Regulatory Affairs.
• Perform PI document QC for accuracy and consistency.
• Global coordination of PI processes and adherence to internal SOPs.

Skills

Advanced writing

Regulatory writing

Communication skills

Team collaboration

Education

Bachelor's/Master's in life sciences or health-related field

B.Pharm/M.Pharm

Tools

MS Word

Adobe Acrobat

Job description

Job Summary

We have vacancy for Product information specialist role in Regulatory Affairs team. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.

Responsibilities

• Management and coordination of good quality Product information documents such as company core data sheets (CCDS), Summary of Product Characteristics (SmPCs), package leaflets (PLs) and labelling in close co-operation with Regulatory Affairs and Pharmacovigilance, including writing PI documents with support from Medical Affairs, Commercial Operations and Global Operations
• Document management and change control of PI documents
• Performing quality control of PI documents for accuracy and consistency
• Global coordination and guidance of internal PI related processes
• Assuring high quality processes, internal guidelines, standard operating procedures internal templates

Qualifications

• Bachelor s/Master s degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college

Requirements

• 4 - 7 years of experience as Product Information Specialist in Pharmaceutical industry
• Advanced writing skills (e.g. SmPC, PL, other regulatory documents)
• Ability to understand complex medical terminologies and convert them into simple language
• Advanced computer and word processing (MS Word, Adobe Acrobat) skills
• Good communication and interpersonal skills
• Ability to prioritise, manage multiple projects meet deadlines while delivering high quality documents
• Ability to work within teams (often remotely) as well as independently
• Positive attitude and willingness to learn and adapt, but also to teach and support co-workers and colleagues around the world
• Ability to keep sight of the bigger picture, while at the same time paying attention to details.
• Ability to work in a highly regulated industry