Senior Specialist

Job Description

ey Responsibilities & Key Result Areas

The major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below:

• Explaining regulations, policies, or procedures
• Ensuring adequate compliance with regulations
• Advising others on matters that are related to regulatory processes and compliance
• Providing correct and accurate technical review of data or reports
• Overseeing the planning, coordination, and management of regulatory documentation activities
• Examining, identifying, and interpreting relevant regulatory guidelines
• Analysing and evaluating laws and regulations that apply to the process of determining the impact on company activities
• Compiling and overseeing the maintenance of regulatory documentation databases or systems
• Coordinating efforts that are related to the preparation of regulatory documents or submissions
• Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.

Core Competency

• High on communication and collaboration, having an ability to manage multiple stakeholders at a time
• 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 command in English (Communicating, writing and speaking)
• Good prioritizing skills and being able to make a just decision also in case of (time) pressure;
• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
• Strong organizational skills and the ability to multitask
• Demonstrated ability in working independently and as part of a team
• Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
• 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 4-5 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.