Job Summary/Main Purpose
The role holder must ensure to adhere with the cGMP principles and to maintain them in an effective manner. Responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under certain regulations.
The Team Lead will report to Manager – Regulatory Affairs and efficiently conduct all duties and responsibilities assigned and or delegated by the Manager. Must ensure to support RA team members as per the need of the department.
Key Responsibilities & Key Result Areas
Supervise daily workflow of Regulatory Affairs specialists or other staff.
Develops strategies to ensure the company’s production activities comply with government regulations.
Serves as a liaison between regulatory bodies and operating divisions of the company.
Prepares and submits applications and reports to applicable regulatory agencies.
Responds to requests for information from regulatory bodies.
Coordinates with operations departments regarding production design and development to ensure compliance with regulations.
Assists with the development of standards for the company’s operating and production procedures.
Maintains current knowledge of regulations applicable to the company.
Monitors regulatory affairs and the effect changes will have on company operations.
Develops and maintains professional relationships in federal, state, and local regulatory agencies.
Performs other related duties as assigned.
Daily report for the activities performed for the assigned activities to be updated to RA Manager.
Maintain and demonstrate a high level of personal and professional integrity while conducting the RA activities
Actively participate in continuous improvement initiatives of the Department
Core Competency
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
Must be able to manage tasks and priorities and easily adapt to changing situations.
Good prioritizing skills and being able to make a just decision also in case of (time) pressure;
Strong organizational skills and the ability to multitask
Must be able to communicate technical, scientific, and regulatory information, both written and verbally
Ability to work in a detail-oriented manner
Must have a teamwork attitude & ability to apply common sense understanding to carry out multi-step instructions
Must be highly organized, self-motivated to learn new things and implement them at workplace
Qualifications/Key Experiences / Functional Knowledge Requirements
Bachelors ( 4 years) / Master’s Degree in Pharmacy
Minimum 6-8 years of experience working in similar role in Pharmaceuticals industry
A Strong Background in Regulatory Affairs and its related activities like - New Registrations, variations renewals etc.
Has strong knowledge of regulatory guidance in multiple regions and industry best practices for drug development.
Strong command in English (Communicating, writing and speaking)
Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.