Description

Manager, Regulatory Consulting

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Technical Skills Required

• Authoring and review of nonclinical dossier sections like Investigator’s Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs).
• Prepare nonclinical documents, summaries and technical reports.
• Toxicology data.
• Author meeting request packages and briefing book for Health agency meetings (specially FDA).
• Respond to global queries pertaining to nonclinical sections.
• Well versed with FDA/EMA/PMDA regulations, ICH guidelines, GLP/GCP requirements

Management Skills

• Leading cross functional teams for regulatory submissions.
• Risk identification and mitigation.
• Managing client expectations

Job Responsibilities

• Contributes to planning for regulatory submissions in assigned region/country/project.
• Responsible for day to day management of project teams and projects.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Acts as a representative of the regulatory department with other departments.
• Supports business development, including generation of repeat business from existing clients and proposal development.
• develops, reviews, and monitors project budgets; reviews client invoicing.
• Monitors personal utilization and utilization of direct reports.
• Acts as a key point of contact for clients and regulatory authorities.
• Provides regulatory advice to Company associates.
• Conducts regulatory research on projects as needed.
• Provides strategic and operational advice to clients.
• Arranges, leads, and reports on client and regulatory agency meetings.
• Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
• Acts as a resource for technical knowledge.
• Participates in quality improvement efforts to increase overall operational efficiency.
• Contributes to the building of regulatory systems and infrastructure needed for GRAS.
• Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
• Develops solutions to complex problems.
• Provides internal training in appropriate areas of expertise to other departments.

Qualifications

Manager, Regulatory Consulting

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Contributes to planning for regulatory submissions in assigned region/country/project.
• Responsible for day to day management of project teams and projects.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Acts as a representative of the regulatory department with other departments.
• Supports business development, including generation of repeat business from existing clients and proposal development.
• develops, reviews, and monitors project budgets; reviews client invoicing.
• Monitors personal utilization and utilization of direct reports.
• Acts as a key point of contact for clients and regulatory authorities.
• Provides regulatory advice to Company associates.
• Conducts regulatory research on projects as needed.
• Provides strategic and operational advice to clients.
• Arranges, leads, and reports on client and regulatory agency meetings.
• Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
• Acts as a resource for technical knowledge.
• Participates in quality improvement efforts to increase overall operational efficiency.
• Contributes to the building of regulatory systems and infrastructure needed for GRAS.
• Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
• Develops solutions to complex problems.
• Provides internal training in appropriate areas of expertise to other departments.

Apply through this link