Syneos Health

Description

Regulatory Consultant (CMC)

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• 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

Primary-

• Strong and practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA)
• Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs for global markets.
• Experience in new MAAs (ROW) will be good to have.
• Review change controls from manufacturing, analytical, packaging, or site changes; provide regulatory impact assessments across global markets.
• Knowledge to support for preparation of regulatory assessment summary/ submission strategy.
• Good experience in liaising with cross functional teams on client side – Project managers, technical, analytical, stability, QA and supply team, Product lead, Site CMC, Regional CMC, Publishing teams and Local regulatory to ensure compliant and on-time submission.
• Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.
• Responsible for training and mentoring of junior team members depending upon project requirements
• Tracking and coordinating the activities for fulfilling regulatory/ CMC commitments to update the databases, prepare and submit the commitment in due time.
• Timely sensitization /escalation within team to maintain compliance and adherence to timelines.

Secondary-

• Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract and strategies.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities
• Hands on experience of RIMS/VEEVA vault with trouble shooting experience (desired)
• Effective communication through email and calls with internal and client stakeholders for updates and clarifications.
• Strong organizational skills and ability to manage multiple priorities in a deadline-driven environment

Qualifications:

• Minimum 6 years of experience required for preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports.
• Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.
• Post approval variation experience is mandatory (for GLOBAL MARKETS – EU mandatory). Pre-approval MAA dossier experience (for ROW) is preferred.
• Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
• 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.
• Advanced skills in Microsoft Office Applications.
• Ability to interact with staff from multiple departments and offices to establish project standards.
• Strong analytical skills, good attention to detail.
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project.

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.