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Sr. Director/Director of Regulatory Affairs

Job Description

Director of Regulatory Affairs - Conshohocken, PA

Description:

The Sr. Director/Director of Regulatory Affairs will provide regulatory support for products in development and/or marketed products. The Sr. Director/Director RA will have high level writing skills, and will be responsible for writing and submission of regulatory documents including INDs, NDAs/sNDAs, briefing documents for meeting with HA, annual reports, amendments, supplements, clinical protocols and clinical study reports. * Participate on multidisciplinary teams and communicate regulatory requirements effectively. * Conduct regulatory intelligence research to assist in the development of strong regulatory strategies. * Review regulatory documents associated with clinical research * Evaluate change controls for drug substances, drug products, test methods and manufacturing and provide the regulatory impact assessment. * Prepare regulatory submissions. * Develop and/or review SOPs, policies, and guidelines to ensure compliance with newly issued or revised regulations and guidance documents.

Qualifications: Masters or PhD Degree in a scientific discipline. 5+ Years within the pharmaceutical industry, at least 3 years in regulatory affairs




About Aerotek:

Our people are everything. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With over 230 non-franchised offices, Aerotek serves 17,000 clients and 300,000 contract employees every year. To learn more, visit aerotek.com.



The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-PA-Malvern
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Pharmaceutical, Research
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-PA-Malvern
Lascena Preddie
6102325815
Snapshot
Aerotek
Company:
US-PA-Malvern
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Pharmaceutical, Research
Store Type:

Job Description

Director of Regulatory Affairs - Conshohocken, PA

Description:

The Sr. Director/Director of Regulatory Affairs will provide regulatory support for products in development and/or marketed products. The Sr. Director/Director RA will have high level writing skills, and will be responsible for writing and submission of regulatory documents including INDs, NDAs/sNDAs, briefing documents for meeting with HA, annual reports, amendments, supplements, clinical protocols and clinical study reports. * Participate on multidisciplinary teams and communicate regulatory requirements effectively. * Conduct regulatory intelligence research to assist in the development of strong regulatory strategies. * Review regulatory documents associated with clinical research * Evaluate change controls for drug substances, drug products, test methods and manufacturing and provide the regulatory impact assessment. * Prepare regulatory submissions. * Develop and/or review SOPs, policies, and guidelines to ensure compliance with newly issued or revised regulations and guidance documents.

Qualifications: Masters or PhD Degree in a scientific discipline. 5+ Years within the pharmaceutical industry, at least 3 years in regulatory affairs




About Aerotek:

Our people are everything. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With over 230 non-franchised offices, Aerotek serves 17,000 clients and 300,000 contract employees every year. To learn more, visit aerotek.com.



The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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