Dr Reddy’s Hiring Team Lead – Labeling & Publishing

Dr Reddy’s Hiring Team Lead – Labeling & Publishing

26 April, 2022

Key Responsibilities:

Labeling and Publishing

Thorough knowledge and familiarity with the guidance’s issued by

US FDA, Health Canada, ad EMEA for labeling and publishing activities.

Support in goal setting for labelling and publishing disciplines.

Appraise self and team in line with the HR policy and procedure in place for

activities.

Prepares and implements regulatory submission plans with the

available resources in accordance with the strategic submission proposals and

plan.

Represent global labelling and publishing team in internal

meetings and present specific topics when needed.

Technically guide and support the team from application filing

through life cycle management for labelling and publishing activities to enable

timely submissions.

Provide oversight to the day-to-day activities of the labelling

and publishing team with interventional support as required.

Monitor process performance continuously and implement process

improvement plans based on RCA and CAPA.

Impart refresher trainings and raise the standards of the team for

labelling and publishing activities in line with the dynamic regulatory

changes.

Ability to estimate resource requisite, hire, and train based on

the projections, role enhancements, and needs that may arise from time-to-time.

To facilitate application fee payment to US FDA and Health Canada

in line with the finance policy and procedure in place.

Automation and Digitization

Responsible for GxP Computer System Validation (CSV) assessment in

accordance with company policy, industry standards and regulatory guidance to

ensure the systems are appropriately validated before use.

Co-ordinate with vendors and cross functional teams for software

upgrade, maintenance, and resolving technical issues.

Identify the mundane tasks that could be digitized and/or

automated for the regulatory affairs function.

Prepare a feasible design proposal, support in development,

testing, implement, and upgrade to ensure application sustainability.

Prepare and maintain SOPs/WIs/guidelines for the applications as

required from time-to-time.

Education & Experience:

Post-Graduation in Pharmacy/life sciences with 10+ years of experience

Seasoned regulatory professional with strong technical expertise in global labelling and publishing activities for pharmaceutical products, biologics, and/or medical devices.

Sound understanding of small molecules with knowledge in scientific, clinical, drug safety information etc.

Apply through this Link

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