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Senior Associate (Sterile Exp-EU Market)
4-9 years
₹ 4L/yr - 14L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Remote
1 vacancy
Senior Associate (Sterile Exp-EU Market)
Syneos Health
posted 4 days ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes.
- Review of Module 2 and 3 related to sterile manufacturing, microbial control, and container closure systems.
- Experience in handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.
- Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers
- For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:
- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
- Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.
- Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.
- Attends client meetings as needed and builds client relationship in support of projects and deliverables.
- Systematically reviews Regulatory Associates or other Senior Associate s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
- Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.
- Assists in training and mentoring of team members depending upon project requirements.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
QUALIFICATION REQUIREMENTS:
- Minimum 4 years of experience in Post approval variation in GLOBAL MARKETS - EU mandatory.
- Masters in Pharmacy (Preferred) or Masters in science/healthcare field, or equivalent combination of education and experience.
- Experience in a work-related area preferred.
- Excellent interpersonal / communication skills.
- Advanced skills in Microsoft Office Applications.
- Strong analytical skills.
- Ability to work independently and to understand and carry out detailed instructions.
- Ability to interact with staff from multiple departments.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
Employment Type: Full Time, Permanent
Read full job description
What people at Syneos Health are saying
Rating based on 3 Senior Associate
reviews
Anonymous · Research & Development
in Hyderabad / Secunderabad
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- Salary - Bad
+5 more
Senior Associate salary at Syneos Health
reported by
35
employees
with 2-9
years exp.
₹6
L/yr - ₹11.6
L/yr
14%
less
than the average Senior Associate Salary in India
View more details
What Syneos Health employees are saying about work life
based on 690 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Syneos Health Benefits
Submitted by Company
Financial Health Learning, Development and Growth Physical Health Employee Resources
Submitted by Employees
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