Manager - Regulatory Consulting

Syneos Health, Inc.; Gurugram District; Hybrid; INR 1,800,000 - 2,400,000; Full time

Job summary

Syneos Health is seeking a Manager, Regulatory Consulting (Office based) in Gurugram/Hyderabad. The role requires 4-5 years in Regulatory Affairs, M.Pharm, and hands-on CMC and lifecycle management experience. Lead product portfolios and guide teams across EU, GCC, AU, APAC/US markets.

The candidate will write INDs and product dossiers, manage daily project activities, and contribute to regulatory strategy, client relations, and training. Strong leadership and communication are essential.

Qualifications

• 4-5 years of experience in Regulatory Affairs
• M.Pharm qualification is mandatory
• Experience as a Regulatory Lead managing a product portfolio
• Hands-on experience in CMC authoring, post-approval variations, and lifecycle management activities
• Experience evaluating post-approval CMC change controls
• Regulatory exposure to EU, GCC, and AU markets; APAC or US experience is an added advantage
• Prior experience in team handling/people management

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.
• May participate in staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, and separations.
• Approves actions on salary, hiring, corrective action, and terminations.
• Reviews time records, expense reports, leave requests, and overtime.
• Advises staff on administrative policies, priorities, and methods.
• Acts as representative of regulatory department with other departments.
• Supports business development and proposal development.
• Develops, reviews, and monitors project budgets; reviews client invoicing.
• Monitors utilization and utilization of direct reports.
• Acts as a key 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 INDs, product registrations, and post-approval maintenance activities.
• Acts as a resource for technical knowledge.
• Participates in quality improvement efforts to increase operational efficiency.
• Contributes to building regulatory systems and GRAS infrastructure.
• Develops reputation for the Company as an industry leader in Regulatory by attending events, authoring articles, and industry involvement.
• Develops solutions to complex problems.
• Provides internal training in appropriate areas to other departments.

Skills

Fluent English

Education

BS in Life Sciences

Tools

Microsoft Office

Job description

Mgr, Regulatory Consulting (Office based) Mgr, Regulatory Consulting (Office based) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know: Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

4-5 years of experience in Regulatory Affairs

( IND- Gurugram / Hyderabad)

M.Pharm qualification is mandatory

Experience as a Regulatory Lead managing a product portfolio

Hands-on experience in CMC authoring, post-approval variations, and lifecycle management activities

Experience evaluating post-approval CMC change controls

Regulatory exposure to EU, GCC, and AU markets; APAC or US experience is an added advantage

Prior experience in team handling/people management

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.

Other Responsibilities

Performs other work-related duties as assigned

Minimal travel may be required (up to 25%).

QUALIFICATION REQUIREMENTS

BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience

Moderate experience in regulatory

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

Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development

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 and budgeting skills

Good people management, project management, 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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.

The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Learn more about Syneos Health. http://www.syneoshealth.com