Mgr, Regulatory Consulting (Office based)

Syneos Health, Inc.; Gurugram District; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Syneos Health in India (Gurugram) invites a M.Pharm candidate with 4-5 years in Regulatory Affairs to join as Manager, Regulatory Consulting (Office based). The role oversees INDs, product registrations, CMC writing, and lifecycle management, with global regulatory exposure and team leadership.

You'll collaborate across departments, mentor staff, and contribute to BD efforts, while ensuring timely regulatory deliverables and adherence to SOPs and client expectations.

Qualifications

• 4-5 years of experience in Regulatory Affairs (IND, dossier management, lifecycle activities).
• M.Pharm qualification is mandatory.
• Experience as Regulatory Lead managing a product portfolio.
• Hands-on experience in CMC writing and post-approval variations.
• Regulatory exposure to EU, GCC, AU markets; APAC or US experience is a plus.
• Experience with people management.

Responsibilities

• Contributes to planning regulatory submissions for assigned region/country/project.
• Manages day-to-day project team activities.
• Line management and staff development.
• Represents regulatory department with other departments.
• Supports business development and proposal development.
• Writes IND and product registration dossiers and regulatory documents.
• Leads client and regulatory agency meetings.
• Provides regulatory guidance to company associates.
• Conducts regulatory research as needed.
• Develops regulatory systems and infrastructure.

Skills

Regulatory affairs

Regulatory leadership

CMC writing

Team management

Regulatory submissions

Education

M.Pharm

BS degree in science

Job description

Mgr, Regulatory Consulting (Office based)

Updated: Today
Location: Gurgaon, HR, India
Job ID:25112535

Description

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

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.

Summary

JOB SUMMARYResponsible for leadership of major assignments and client relationships. In consultation with the line manager, responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. Contributes to business development for regulatory functions.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.