Sr Regulatory Consultant (CMC, EU mkt) (Office based)

Sr Regulatory Consultant (CMC, EU mkt) (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

• 6–9 years of Regulatory Affairs experience, preferably in biologics.
• IND- Gurugram / Hyderabad
• Strong expertise in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities.
• Experience handling EU and ROW CMC variation submissions.
• Hands-on experience with Drug Substance, Drug Product and site transfer variations.
• Strong knowledge of global regulatory requirements, with EU market experience mandatory.

Ability to work independently, resolve issues proactively, and manage multiple priorities in a fast-paced environment.

JOB RESPONSIBILITIES

• Responsible for day-to-day contribution to project teams and projects.

• Acts as a representative of the GRAS regulatory department with other departments.

• Contributes technical expertise to proposals and assists with Business Development initiatives.

• Understands project budgets, scope of projects, allocated hours, and tracks compliance.

• Interacts with internal and external personnel, clients, and technical experts on projects.

• Conducts regulatory research on projects as needed.

• Provides operational advice to clients.

• Prepares consulting reports under guidance.

• Arranges, leads, and reports on client meetings.

• Contributes to regulatory agency meetings.

• Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.

• Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.

• Acts as a resource for technical knowledge.

• Participates in quality improvement efforts to increase overall operational efficiency.

• Contributes to the building of the 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 and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.

• Provides internal training in appropriate areas of expertise to other Departments.

• May act as a Line Manager to a small team, dependent on the location.

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. 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.

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.