Senior Specialist Regulatory Affairs

Job Description

The Sr. Specialist RA must ensure to adhere with the cGMP principles and to maintain them in an effective manner. Assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. Regulatory affairs Sr. Specialists are also responsible for collecting, gathering, compiling, and preparing the dossier needed for registration and submission to regulatory agencies.
The Regulatory Affairs Sr. Specialist 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 & Accountability:
Key Responsibilities & Key Result Areas
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.
Performing all the aligned task in order to achieve the regulatory requirements from the health authorities
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:
- Education
Bachelors ( 4 years) / Master s Degree in Pharmacy
- Experience:
Minimum 5-6 years of experience working in similar role in Pharmaceuticals industry
- Training:
Key Competencies:
Strong command in English (Communicating, writing and speaking)
Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
Technical Competencies:
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.