Regulatory CMC Manager/Regulatory Consulting at Syneos Health

Popis pracovní pozice:

Nejnovější informace o práci od Syneos Health na pozici Regulatory CMC Manager/Regulatory Consulting. If the Regulatory CMC Manager/Regulatory Consulting volné místo v Srbeč odpovídá vaší kvalifikaci, zašlete svou aktuální žádost nebo CV přímo přes aktualizovaný portál Jobkos.

Vezměte prosím na vědomí, že hledání práce nemusí být vždy snadné, protože kandidáti musí splňovat určité požadavky stanovené společností. Doufáme, že kariérní příležitost v Syneos Health na pozici Regulatory CMC Manager/Regulatory Consulting níže odpovídá vaší kvalifikaci.

Regulatory CMC Manager/Regulatory Consulting - hybrid/remote (Serbia, UK, Portugalsko)

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 Firma 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

General Pozice Summary

The Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams and may contribute to strategic Regulatory CMC discussions.

Key Duties and Responsibilities

• Authoring of CMC sections for Marketing Authorisations dossiers.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

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 Firma, 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 Firma, 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 Práce are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each Země in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Firma 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.

Informace o práci:

• Firma: Syneos Health
• Pozice: Regulatory CMC Manager/Regulatory Consulting
• Místo výkonu práce: Srbeč
• Země: CZ

Jak poslat žádost:

Po přečtení a pochopení kritérií a minimálních požadavků na kvalifikaci uvedených v informacích o pracovní pozici Regulatory CMC Manager/Regulatory Consulting at the office Srbeč výše, si okamžitě připravte dokumenty k žádosti, jako je průvodní dopis, životopis (CV), kopie diplomu, výpis známek a další přílohy. Odeslat můžete přes odkaz Další strana níže.

  Regulatory CMC Manager/Regulatory Consulting at Syneos Health

Zveřejněno: 3 months ago

Popis: Regulatory CMC Manager/Regulatory Consulting - hybrid/remote (Serbia, UK, Portugalsko)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer suc...

Firma: Syneos Health | Lokalita: Srbeč

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