Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

Syneos Health; Brasil; Presencial; BRL 180 000 - 280 000; Tempo integral

Resumo da oferta

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant focused on small molecule development with Veeva RIM expertise. The role supports global regulatory CMC strategies for marketed and development products and provides regulatory guidance to cross-functional teams.

You will review CMC sections, develop global strategies, and contribute to submissions with emphasis on small molecules and Veeva RIM authoring. Join a team driving patient impact.

Qualificações

• Experience in writing and compiling CMC submissions.
• Strong interpersonal and communication skills.
• Proficiency with regulatory guidelines (FDA, EMA, Health Canada, LATAM, ICH).
• Strategic thinking and problem solving skills.
• Ability to collaborate across cross-functional teams.

Responsabilidades

• Reviews CMC sections of regulatory submissions.
• Contributes to the development of global regulatory CMC strategies for commercial products.
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions.
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.

Conhecimentos

CMC expertise

Regulatory guidance

Global submissions

Cross-functional collaboration

cGMP knowledge

Strategic thinking

Formação académica

Bachelor's degree in life sciences

Ferramentas

Veeva RIM

Descrição da oferta de emprego

Description

Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

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

General Position Summary The Chemistry Manufacturing Controls Manager will supportthe execution of global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for a small molecule. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Key Duties & Responsibilities

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Providesregulatory CMC guidance to cross-functional teams and key stakeholders
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Required Education Level & Experience

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiencyin regulatory (FDA, EMA, HealthCanada, LATAM, Middle East,and ICH) guidelines
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and strongproblem solvingskills
• Ability to collaborate and communicate in an open, clear, complete,timelyand consistent manner
• Strong senseof planning and prioritization, and the ability to work with all levels of management
• Capable of strategic thinking with ability to resolve complex and ambiguous situations
• Sound knowledge of cGMP, FDA, EMA, ICH
• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

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

CMC expertise in small molecule experience with support to Regulatory team with Global expansion on multiple markets. Veeva RIM authoring is required.