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.
Post : Sr Regulatory Consultant (Biologics)
Job Description
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.
Skills required :
• Required minimum 7-8 years of experience of which minimum 5 years into Biologicals Regulatory CMC
• Candidates serving Biotech companies will be preferred
• Candidates having experience of Authoring Module-3
• Technically strong knowledge in Biologics and CMC.
• Exposure in US, Australia, EU, Canada, Japan,China, Brazil market (CMC authoring)
• Sound knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
• Ability to motivate fellow team members, provide troubleshooting, tracking deadlines and potential to act as a first- or second-degree reviewer
• Excellent Communication skills
• Effective management of individual workload; Analytical capabilities, familiarity and comfort with regulatory concepts; Professional service mentality.
• Knowledge/experience on review and mapping of technical documents like COA's, specifications, Analytical/process validation reports, development reports, stability reports and protocol to respective CTD sections.
• Should have good understanding or ability to search existing and new CMC guidelines for any region.
• Advance level knowledge on steps undertaken from CMC perspective for any CMC sections gap assessments for any baseline or site transfer activities.
Candidate Profile
• BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. PhD preferred.
• Moderate regulatory, 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.
• Experience in niche submissions such as ODD, PIP/PMP an advantage.
• 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.
• Problem-solving and decision-making 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.
Additional Information
Experience : 5+ years
Qualification : BS degree ; PhD preferred
Location : Pune
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th October, 2022
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