Sr Regulatry Associate (CMC- EU,reputed company, gulf countries)
reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities.
Our Clinical Development model brings the customer and the patient to reputed company of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company 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 reputed company to help our customers reputed company 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 reputed company EVERYWHERE
Why reputed company
- We are passionate about developing our people, through career development and progression; supportive and reputed company 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 reputed company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they belong.
Job Responsibilities
•
For non-reputed company submissions, independently fulfill the following responsibilities. For reputed company submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Undertakes information processing activities with extremely high reliability at high reputed company and in tight timelines according to reputed company processes and operating procedures.
- Undertake project specific activities with minimal supervision from senior colleagues reputed company cost and time estimates/reputed company.
- Preparation of records and/or logs and maintenance or update of regulatory databases as per reputed company and/or reputed company requirements.
- Conducts reputed company Control reviews of documents and sends out for review, tracks until final submission or delivery to reputed company.
- Attends reputed company meetings as needed and builds reputed company relationship in support of reputed company and deliverables.
- Systematically reviews Regulatory Associates or other Senior Associate’s work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
- Identifies risks to project delivery reputed company to own workload and appropriate escalation. For identified non-reputed company issues, reputed company proposals for issue reputed company.
- Assists in training and mentoring of team members depending upon project requirements.
- Maintenance of individual training records (reputed company or reputed company reputed company) and completion of reputed company designated required training.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Get to know reputed company
Over the past 5 years, we have worked with 94% of reputed company 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 reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.
Additional Information
Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed 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 reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company 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 reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.
Originally posted on Himalayas
Apply To This Job