Apply for Work from Home Regulatory Consultant / Sr Reg Consultant (CMC- API) at Syneos Health – B. Pharma/ M. Pharma/ Lifescience/ Ph. D

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are 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.

Post Name: Regulatory Consultant / Sr Reg Consultant (CMC- API)

Location: WFH

 Skills required : 

• Minimum 5 years of experience in authoring and reviewing of Module 3 (CMC) for regulatory Consultant and minimum 7 years of Sr Regulatory consultant
• Exposure in EU/ ROW markets
• Sound knowledge of Packaging Site transfers and Drug product variations. 
• Experience in API site changes preferred
• Good understanding of manufacturing and all aspects related to product development
• Excellent Communication skills  

Job 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. 

Qualification Requirements  

• BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience. 
• 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. 

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