Syneos Health is hiring B. Pharma/ M. Pharma/ B. Sc/ Ph. D/ M. Tech as a Regulatory Consultant – Apply Now

Exciting career opportunity alert! Syneos Health is seeking talented individuals with backgrounds in B. Pharma, M. Pharma, B. Sc, Ph. D, or M. Tech in Medical Devices to join us as Regulatory Consultant. This WFH (Work From Home) position offers flexibility and the chance to make a significant impact in the healthcare industry. If you’re passionate about regulatory affairs and ready to contribute your expertise to a global leader in biopharmaceutical solutions, we want to hear from you. Explore this opportunity further and take the next step towards an enriching career journey with Syneos Health!

Skills required :

• Minimum 5 years of experience in authoring and reviewing of Module 3 (CMC)
• Exposure in EU/ ROW markets is Mandatory
• Preferred candidates with experience in sterile (Injectables)
• Preference to have hands on knowledge of systems (Veeva, RIMS or alike document management systems , reliant etc).
• Sound knowledge of Packaging Site transfers and Drug product variations
• Experience in Drug product site transfer experience – Packaging site transfers , manufacturing process etc
• Excellent Communication skills

Knowledge

• 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.

Job responsibilities
For non-complex and complex submissions, independently fulfill the following 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.

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