- Complete the assigned activities diligently, by using appropriate client specific standards and tools, confirming to regulatory submission milestones and applicable regulatory obligations.
- Provide operational support within the team to execute designated tasks associated with submission.
- Accountable for delivering designated submissions with quality and timely as per applicable policy, SOP/Work, instructions, guidelines, or service level agreement.
- Commit to completing required on-the-job training courses to ensure training compliance is preserved.
- Continuous improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities.
- Support activities related to Product License Portfolio in a timely and quality manner.
- Execute the assigned activities to ensure completion of project tasks and/or milestones.
- Capable of understanding and implementing the basic team effectiveness skills like commitment, feedback, trust, and teamwork.
- Apply necessary technical skills to complete the assigned regulatory operational activities to support submissions to global health authorities.
- Performs work in a structured environment under direction from supervisor.
- Exercises judgment to complete assigned tasks and has significant reliance on supervisor.
- Uses established procedures to perform assigned tasks.
- Participates and contributes as a team member and is responsible for certain team deliverables.
Education, Experience and Skills:
- bachelors / masters Degree in Pharmacy / Science or other relevant domains.
- Fundamental working experience of 2-4 years in RA/QA/AR&D/R&D/QC requirements.
- Awareness on the tools used in regulatory activities like publishing, artwork, change control management.
- Experience in managing a matrix environment.
- Proven experience in decision making and tight deadlines.
- Technically adept at using IT systems and software.
- Fast learner with proven ability to adapt to changing demands.
- Good knowledge of English, spoken and written.
