Remote Job Opportunity
Syneos Health Requires Regulatory Consultant (Sterile Experience)
Details are Provided below
1. Job Type(Full time ) : India Remote And India Gurugram-Hybrid
2. Position: Regulatory Consultant (Sterile Experience)
3. About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. This company translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Their Clinical Development model brings the customer and the patient to the center of everything that we do. They are continuously looking for ways to simplify and streamline their work to not only make Syneos Health easier to work with, but to make them easier to work for.
Whether you join this company in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help their customers achieve their goals. They are agile and driven to accelerate the delivery of therapies, because they are passionate to change lives.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
They are passionate about developing their people, through career development and progression; supportive and engaged line management;
technical and therapeutic area training; peer recognition and total rewards program.
They are committed to their Total Self culture - where you can authentically be yourself. Their Total Self culture is what unites them globally, and they are dedicated to taking care of their people.
They are continuously building the company they all want to work for and their customers want to work with. Why? Because when they bring together diversity of thoughts, backgrounds, cultures, and perspectives - they are able to create a place where everyone feels like they belong.
4. Job Responsibilities
a. Primary
- Experience in regulatory submissions for sterile drug products, including aseptic and
terminal sterilization processes.
- Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems.
- Post approval variation experience is mandatory for EU market.
- Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions.
- Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.
- Preparation of regulatory assessments and submission strategies specific to sterile dosage forms.
-Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness.
-Provides regulatory support during inspections and audits related to sterile manufacturing.
-Change control assessments and preparation of regulatory impact summaries.
-Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers.
-Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation.
b. Secondary:
-Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines.
-Effective communication through email and calls with internal and client stakeholders for updates and clarifications.
-Supports and mentors junior team members depending on project needs.
-Hands-on experience with RIMS/Veeva Vault.
-Open to working in cross-cultural and virtual team settings.
5. Qualifications
Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master's degree in pharmaceutical sciences (preferred) or Master's degree in other life sciences.
Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
Excellent interpersonal / communication skills including excellent written and verbal communication skills.
Excellent customer service skills, with the ability to work both as a team member and independently.
Good quality management skills.
Advanced skills in Microsoft Office Applications.
Ability to interact with staff from multiple departments and offices to establish project standards.
- Good initiative, adaptability, and pro-activity.
Strong analytical skills, good attention to detail.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
Fluent in speaking, writing, and reading English.
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