Syneos Health is inviting applications for the post of Regulatory Consultant.
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. It translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Its Clinical Development model brings the customer and the patient to the center of everything. It is continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
About the Opportunity
Syneos Health is inviting applications for the post of Regulatory Consultant.
Roles and Responsibilities
- Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
- Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
- Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
- Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
- Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
- Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
- Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
- Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
- Prepare training materials and share best practices in the regulatory area, both internally and externally.
- Participate as regulatory support in internal or external project audits.
- Participate as regulatory support on internal cross-functional initiatives.
- Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
- Provide support in oversight to team members in the execution of their project responsibilities.
- Capable of identifying when to ensure line support required to provide additional guidance and direction.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
Eligibility Criteria
- Minimum 5 years of experience in Regulatory
- Should have EU mkt experience.
- Should have good exposure in Post approval changes and Drug product variation.
- Experience in Sterile(injectibles) is preferred.
- 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.
How to Apply?
Click on the link provided below to apply.
Contact Information
In case of any query, please contact: (+91) 9876 9300
Click here to apply.
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Source: Lawctopus
