Website Dr. Reddy Laboratories
Post Name: Regulatory Affairs Specialist
Job Description:
We are looking for a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals.
This role is pivotal in managing activities pertaining to new application submissions for Europe through DCP, MRP, NP. Collaboration with European Regulatory authorities and internal teams will be essential to ensure the regulatory compliance for new applications.
Roles & Responsibilities:
Should have an regulatory experience in Europe market new application submissions
Preparation, review and submission of new applications through DCP, MRP, NP for EU.
You will be responsible for preparation and review of m1 documentation in-line to the m2-5 documents.
You will be responsible for preparation of artworks, including product information to ensure regulatory compliance.
Direct Interaction with EU regulatory authorities.
Handling of deficiencies and timely response to regulatory agencies
Good interpersonal skills with command on English language to communicate with Regulatory agencies & IL Customers
Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams
Support the manufacturing sites during Regulatory audits
You will be responsible for performing other tasks and duties assigned by the immediate supervisor.
You will be responsible for preparation and submission of the regulatory dossiers to Europe.
You will be responsible for preparation and review of m1 documentation in-line to the m2-5 documents.
You will be responsible for preparation of artworks, including product information to ensure regulatory compliance.
You will be responsible for delivering registration goals with minimum supervision.
You will be responsible for monitoring and follow-up of product filings for early approval of applications with regulatory authorities.
You will be responsible for participating in the industry association to keep abreast of regulations.
You will be responsible for creation and revision of new or existing SOPs (Standard Operating Procedures).
You will be responsible for developing and maintaining a good relationship with the Europe health authorities.
You will be responsible for performing other tasks and duties assigned by the immediate supervisor.
Qualification:
Educational qualification: M.SC or M.pharm
Minimum work experience: 8 to 12 years of experience in regulatory affairs preferably in Europe registrations (Including M1)
Skills & attributes:
Knowledge of EMA guidelines.
Proficiency in spoken and written English.
Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.
Excellent interpersonal and communication skills.
Attention to detail and the ability to multi-task and meet strict deadlines.
