Regulatory Consultant (CMC / EU Market Exp)

Description

Regulatory Consultant (CMC / EU Market Exp)

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

For non-complex and complex submissions, independently fulfill the following responsibilities :

Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines

Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy.

Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.

Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.

Manage and / or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.

Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.

Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.

Prepare estimates for conducting regulatory services as part of single or multiple service proposals.

Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.

Ensure compliance with appropriate global regulatory requirements and the company's policies and processes.

Prepare training materials and share best practices in the regulatory area, both internally and externally.

Participate as regulatory support in internal or external project audits.

Participate as regulatory support on internal cross-functional initiatives.

Contribute to the creation and / or maintenance of SOPs and other process related documentation as required.

Provide support in oversight to team members in the execution of their project responsibilities.

Capable of identifying when to ensure line support required to provide additional guidance and direction.

Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

QUALIFICATION REQUIREMENTS

Should have 5+ years total work experience and 4+ years relevant experience in Regulatory Affairs.

Should have m arkets experience in EU (mandatory) , GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) , MEA

MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science / regulatory. Moderate pharmaceutical / medical device related experience.

Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, 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.

Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred.

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.

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

Provide regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, legal entity name changes (LENC) and other lifecycle maintenance activities. An experience in product development projects, including product development documents and regulatory agency submissions, implementing / managing project regulatory activities, and supporting clients and project teams, would be preferred.

Skills Required

Regulatory Submissions, trackwise , Microsoft Office Applications