Bachelors Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Masters Degree preferred for senior-level roles.
RAC certification is a plus.
Experience(s)
Minimum 3-6 years of relevant Regulatory Affairs experience required.
Familiar with the Life Sciences Industry, preferably Regulatory
Understanding of global regulations related to Pharmaceuticals, Medical Devices, and Biologics in the context of service offerings.
Experience in creating customer-facing materials.
Able to work independently.
Fluent in English
Technical Skills
- Hands-on experience related to Regulatory Processes including related IT systems including Document Level Publishing and Submission Level Publishing.
- DMS tools like Veeva Vault, CARA, D2 are preferred.
Soft Skills
Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
Competencies
- Valuable Communication (Writing and Verbal)
- Customer Focused
- Drive to deliver superior quality proposals.
- Strong Time management
Personal Traits
Positive Attitude, Initiative and Commitment, Detailed Oriented, Team player, Focused and sincere, Perseverance
Roles and Responsibilities
- Member of the Centre of Excellence team responsible for the Lifecycle Management of assigned products.
- Document level Publishing: Author and Publish the technical regulatory documents based on the clients product requirements.
- Submission Level Publishing: Compiles the dossier in the required format for submission to the relevant agencies.
- Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions.
- Manage various activities under product life cycle management (Registration, Variation, Renewals, and submission)
- Prioritize target activities and produce high-quality deliverables.
- Ensure
📌 Associate II-Publishing (Bengaluru)
🏢 Celegence Systems
📍 Bengaluru
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