Assistant Manager - Quality & Regulatory - Pharma

Company : One of the leading Pharma Co. (part of an MNC)

Designation : Asst. Manager - Quality and Regulatory, Business Unit Pharma

Location : Mumbai

For the region : Pan India

Age Group: 25- 35 years

Functional Reporting to: Head, Business Unit Pharma, India office

HR / Administrative Reporting to: General Manager, India office

Job description / responsibilities are as follows:

- Support quality/regulatory queries from customer including quality agreements, vendor approval requests and other quality/regulatory requests.

- Being a key point of contact collect, evaluate, and collate information from the customer for the standard and non-standard document requests including questionnaires, customer specification reviews, queries and work with global team for preparing response to the customer within the set timeframe.

- Handling of quality complaints received from customers with the thorough investigation and responsible to coordinate with global team for the receipt of the investigation report on time.

- Visit to customer manufacturing site to understand and resolve quality complaints on time.

- Maintain and update of regulatory documentation.

- Handling customer questionnaires as per the customer request.

- Coordinating for Technical Agreements, Audits between global team and customers.

- Monitoring and maintaining complaint status file on monthly basis.

- Proactively work with global quality team to create new statements as per current regulatory guidelines. (i.e. IPEC, NDMA, TGA compliance, CHP compliance)

- Responsible for preparation and finalization of regulatory standard documents based on the business/ market requirements.

- Create monthly customer request reports to identify trends and identify opportunities for improvement

Requirements :

- B. Pharm/ M. Pharm/PG with 3-4 years of experience in regulatory and quality department of pharmaceutical manufacturer or excipient manufacturing/distribution Company.

- Additionally, Diploma/ Degree holder in regulatory affairs will be preferred.

- Excellent communication skills in written and spoken English.

- Candidate must understand the regulatory and quality queries raised by customers and respond with the proper interpretation skills.

Excellent interpersonal skills with positive attitude and team player.