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

Syneos Health, Inc.; Morrisville (NC); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking a Sr Regulatory CMC Consultant specialized in Small Molecule and Veeva RIM must-have expertise, for a global remit including the US, Canada and EMEA. The role emphasizes strong NA regulatory strategy, CMC knowledge, and collaboration across functional teams.

The incumbent will support regulatory planning, submissions, and compliance to advance development programs while ensuring alignment with global regulatory expectations and timelines.

Formación

• Bachelor's, Master's or PhD in life sciences (Biology, Chemistry, Pharmacy, Regulatory Affairs or related).
• Typically requires 8 years of pharma/biotech industry experience or equivalent.
• Experience with US/Canada regulatory submissions and CMC inputs is highly desirable.

Responsabilidades

• Supports North America regulatory strategy under guidance of regional/global leads.
• Identifies regulatory requirements for submissions in North America.
• Manages preparation, submission and approval processes for NA regulatory applications.
• Provides technical regulatory input for key product development or registration documents.
• Ensures submissions comply with current regulations and guidance.

Conocimientos

Regulatory affairs

Regulatory strategy

Regulatory submissions

Written communication

Verbal communication

Teamwork

Planning

Educación

Biology / Chemistry / Pharmacy / Regulatory Affairs (Life sciences)

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.

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

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.

Summary

General Position Summary Regulatory Strategy Manager will be responsible for overseeing the development of global regulatory strategy for development product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s) including supporting clinical trial related activities. This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development. Key Duties and Responsibilities

Key Duties and Responsibilities

• Supports North America regulatory strategy under guidance of regional and global regulatory lead, as needed
• Identifies regulatory requirements for submissions for North America, as needed
• Manages process for preparation, submission and approval or regulatory applications within North America, as needed
• Provides technical regulatory input for key product development or registration documents
• Works to ensure compliance of regulatory submissions with current regulations and guidance