Executive Regulatory Affairs

The position will be an Executive level in RA department. Main focus of the candidate will be handling Pharmacovigilance & Regulatory compliance activity.

Profile and job description

Scope & Missions:

Complaints management  quality & safety

Product complaint management ( to be confirmed with QA)

Centralization of PC

Supervise investigation and conclusion

Communication of the result to customer and others stakeholders involved in the process

Reporting & metrics

Maintenance Quality System management for product complaint management

Vigilance:

Local QPPV in India

Implementation of the process according to Corporate SOP

Unique contact point for safety notification in Indian territories

Initiate case processing ( send to corporate)

Documentation of case

Local literature in key local publication in order to identify some case report published in the literature

Local regulatory watch

Local PSUR schedule management and PSUR management for local products ( if any)

Local signal detection for local products if any

Management of dealers and distributors: SDEA, audit, … reconciliation….

Maintenance of Quality system management

Maintenance of PVMF according to template provided by Corporate

Regulatory Compliance activity:

Ensuring compliance with regulations set by the CDSCO Indian FDA, Medicines and Healthcare products Regulatory Agency (MHRA), USFDA, EU guidelines and other regulatory bodies

Creating and/or maintaining technical files and other regulatory documents / files related to products license, new product registrations or site specific manufacturing registration / re-registration

Uploading the documents in SUGAM portal and verifying updates or status

Liaising with certification / notifying body for system and product certification

Medical information management

Administrative tasks for regulatory submission

KEY Expertise :

Strong knowledge in pharmacovigilance, Regulatory compliance & Product Complaint management  ( EU regulation, GVP,)

Case processing

PSUR

Quality system management

Medical device vigilance knowledge would be interesting

 Pharmacist having 3 or 4 years experience

 Skills :

Rigorous, organized.

Ability to deal with different type of activities

Location: Taloja, Navi Mumbai