Cipla regulatory writer’s job vacancies

Job Overview

Are you looking to play a pivotal role in the world of regulatory medical writing? We invite you to explore the career opening of Team Member in Regulatory Writing (Requisition ID: 78805) within our dynamic and innovative organization. If you have a passion for preparing regulatory medical writing documents and are ready to make a significant impact, this opportunity could be the perfect fit for you.

About the Role

As a Team Member in Regulatory Writing, your primary responsibility will be to provide crucial support to our Regulatory Affairs (RA) team. You will be tasked with preparing regulatory medical writing documents that contribute to dossier filing and renewal processes. This role holds a key position in ensuring the success of product registration and lifecycle management on a global scale, excluding India.

Key Responsibilities

Document Preparation: Create medical writing documents that form the foundation of product registration and lifecycle activities on an international scale.
Regulatory Insights: Offer valuable insights to the RA team, aiding in the development of regulatory strategies for European, WHO, MCC, and US regulatory bodies. This involves comparing country-specific product information and guidance to facilitate strategic decision-making.
Query Response: Prepare well-structured documents as responses to global regulatory and customer queries. This could include scientific justifications, bio-waiver explanations, and regulatory strategy documents.
Cross-Functional Collaboration: Collaborate with various cross-functional teams including Business Development (BD), packaging, Regulatory Affairs (RA), and Pharmacovigilance (PV) to enhance the efficiency of query resolution and document quality.

Required Qualifications

Education: A Bachelor’s or Master’s degree in Pharmacy is essential to excel in this role.
Experience: You should ideally have 1 to 4 years of hands-on experience in the field of regulatory medical writing.

Key Competencies and Skills

Communication: Demonstrating clarity of thought and comprehension through effective communication skills.
Potential for Growth: Displaying the potential for personal and professional growth within the organization.
Domain Knowledge: Possessing a strong grasp of job-related knowledge, especially in the pharmaceutical domain.
Presentation & Interpersonal Skills: Exhibiting strong presentation and interpersonal skills where relevant.
Analytical Abilities: Showcasing analytical and problem-solving capabilities, enabling effective comprehension.
Result Orientation: Demonstrating a focus on productivity and achieving results where applicable.
Attitude: Displaying a positive and proactive attitude towards tasks and responsibilities.