Head - Regulatory Affairs/QA - Pharma

Discipline - Marketing

Subsector - Direct Marketing

Location - Hyderabad

About our Client - Our client is one of the largest global companies dedicated to Healthcare. They touch the lives of consumers in multiple ways and are known for the R&D globally. They have operations in over 150 countries and have over 100000 employees working for them. With their growing presence in India, they are looking at an entrepreneurial individual who would be able to Head Regulatory Affairs at their Shared service Center based out of Hyderabad.

Job Description - Reporting to the Country head, your job responsibility entails:

- Submitting and tracking registration/re-registration applications with the DCGI office and the Dept. of Telecommunications Office.

- Liaising with product divisions and obtaining relevant details for filing changes to the approved products/licenses.

- Access the Enterprise Change Orders/ Change controls from the product divisions and continuously ensure regulatory compliance.

- Reviewing and processing customer complaints for products within the Field Event Reporting system.

- Assist in proper implementation of corrective actions in the country and inform Local Authorities about product recalls and field corrections

- Assist in preparation, implementation and control of the Quality Management System's documentation, including Quality Manuals, Standard Operating Procedures, and Work Instructions, in compliance with Local, Regional, and Corporate Policies and Objectives, International Standards (ISO 9001/ISO 13485), and national and international statutory & regulatory requirements, that apply to the products, processes, and activities.

- Providing support to the various divisions for effective and efficient implementation of the Quality Management System.

- Assist in Internal and External Quality Systems Audits and corrective action implementation.

- Performing random audits of a selected percentage of internally developed dossiers prior to submission, during Health Authority review or post-approval.

The Successful Candidate - You are a Btech/B Pharma/BE Biomedical graduate with a minimum of 10 years of experience in Regulatory Affairs/ Quality Assurance in working with Pharmaceutical Giant.. You posses relevant experience in a medical device environment; knowledge of Quality System Regulations (QSR) preferred with atleast 3-5 years of experience handling product customer complaints. You have strong communication and inter-personal skills, ability to work under pressure and ambiguity and are hardworking, diligent, self- starter, quick learner.

What's on Offer - An attractive remuneration with decision making authority.

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