Regulatory Manager (CMC, EU & Japan/China) Syneos Health

5.0 - 9.0 years

0 Lacs

haryana

On-site

As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In our Clinical Development model, we prioritize placing the customer and the patient at the center of all our activities. We strive to simplify and streamline our processes, not only to enhance our interactions with clients but also to create a more conducive working environment for our employees. Whether you are engaged in a Functional Service Provider partnership or operating in a Full-Service setting, you will collaborate with a team of enthusiastic problem solvers who are committed to innovating and assisting our clients in achieving their objectives. At Syneos Health, we are agile and have a strong drive to expedite the delivery of therapies because we are deeply passionate about making a positive impact on people's lives. As part of our company, you will discover the significance of working in an environment where your contributions matter globally. We are dedicated to the growth and development of our employees through various means such as career advancement opportunities, supportive and engaged line management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our commitment to the Total Self culture ensures that you can be your authentic self at work. This culture unites us globally and underscores our determination to prioritize the well-being of our employees. By fostering a diverse and inclusive workplace that values different perspectives, backgrounds, and cultures, we aim to create a sense of belonging for everyone. In your role, you will have the opportunity to engage with the vast experience of Syneos Health. Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites involving 675,000+ trial patients. At Syneos Health, we encourage you to challenge the status quo, take initiative, and adapt to the highly competitive and dynamic environment we operate in. We are continuously evolving and striving to become the company that everyone desires to work for and that customers prefer to work with. Our ultimate goal is to harness the power of diverse thoughts, backgrounds, and perspectives to create a workplace where everyone feels included and valued. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive. The Company reserves the right to assign additional tasks, duties, and responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. The Company will determine what constitutes equivalence to the qualifications mentioned. This job description does not create an employment contract and is intended to comply with all relevant legislation, including the EU Equality Directive and the Americans with Disabilities Act. Accommodations will be provided as necessary to enable employees or applicants to perform essential job functions.,

Posted 2 weeks ago

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Executive - Regulatory Affairs (API) Animal Health People Genix

3.0 - 8.0 years

5 - 7 Lacs

Bengaluru

Work from Office

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates working in formulations may skip this job post.

Posted 1 month ago

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