Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have (EMEA /US/Canada)

Syneos Health, Inc.; EE. UU.; A distancia; CAD 110.000 - 170.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Sr Regulatory CMC Consultant focused on Small Molecule and Veeva RIM. This role supports North American regulatory affairs, CMC submissions, and surveillance across EMEA, US and Canada.

The candidate will bring extensive regulatory experience and work within cross-functional teams to drive compliant, timely submissions. The ideal candidate has deep knowledge of Regulatory affairs, strong communication skills, and can plan and prioritize tasks effectively in a

Formación

• Bachelor's, Master's or PhD in biology, chemistry, Pharmacy, Regulatory Affairs or life sciences.
• Typically requires 8+ years in pharma/biotech or related field.
• Strong knowledge of North America regulatory processes and drug development concepts.

Conocimientos

North America regulatory affairs

Regulatory submissions & surveillance

Drug development concepts

Regulatory guidelines

Written & verbal communication

Team collaboration

Planning & prioritization

Educación

Bachelor's/Master's/PhD in Life Sciences or Regulatory Affairs

Herramientas

Veeva RIM

Descripción del empleo

Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have (EMEA /US/Canada)

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.

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

Required Knowledge/Skills

• Good knowledge of North America regulatory affairs framework
• Understanding of requirements and processes to maintain a product on market, report, and surveillance
• Understanding of drug development and related concepts
• Ability to assess and understand regulatory guidelines
• Strong written and verbal communication skills
• Ability to work effectively within a team environment
• Ability to plan, prioritize and contribute to work and projects in systematic and efficient manner

Required Education Level & Experience

• Bachelor's, Master's or PhD degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
• Typically requires 8 years of experience in the pharmaceutical or biotech industry or in a related field, or the equivalent combination of education and experience

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.