The Regulatory Affairs Manager is responsible for supporting development and execution of ... Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field ...
The Regulatory Affairs Manager is responsible for supporting development and execution of ... Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field ...
Regulatory Affairs Manager
Columbia, SC · On-site +1
$96K - $125K/yr
The Regulatory Affairs Manager is responsible for supporting development and execution of ... Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field ...
Regulatory Affairs Manager
Columbia, SC · On-site +1
$96K - $125K/yr
The Regulatory Affairs Manager is responsible for supporting development and execution of ... Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field ...
NY · On-site
$60 - $80/hr
Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality ... Certification in regulatory affairs, quality management, compliance, auditing preferred. #J-18808 ...
NY · On-site
$60 - $80/hr
Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality ... Certification in regulatory affairs, quality management, compliance, auditing preferred. #J-18808 ...
Regulatory Affairs Manager
Columbia, SC · On-site
$100 - $125/hr
Day The Regulatory Affairs Manager is responsible for supporting development and execution of ... Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field ...
Regulatory Affairs Manager
Columbia, SC · On-site
$100 - $125/hr
Day The Regulatory Affairs Manager is responsible for supporting development and execution of ... Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field ...
NY · On-site
$80 - $100/hr
Regulatory Affairs Manager - Poland** to support regulatory strategy, submissions, lifecycle ... Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality ...
NY · On-site
$80 - $100/hr
Regulatory Affairs Manager - Poland** to support regulatory strategy, submissions, lifecycle ... Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality ...
Regulatory Affairs Manager
Niles, IL · On-site
Exceptional Management Skills Job Overview: Our global client has a long and reputable history of ... Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering ...
Regulatory Affairs Manager
Niles, IL · On-site
Exceptional Management Skills Job Overview: Our global client has a long and reputable history of ... Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering ...
Regulatory Affairs Manager
Santa Clara, CA · On-site
$120K - $145K/yr
Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...
Quick apply
Regulatory Affairs Manager
Santa Clara, CA · On-site
$120K - $145K/yr
Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...
Regulatory Affairs Manager
Santa Clara, CA · On-site
$120K - $145K/yr
Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...
Quick apply
Regulatory Affairs Manager
Santa Clara, CA · On-site
$120K - $145K/yr
Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...
Regulatory Affairs Manager
Santa Ana, CA · On-site
$38 - $48/hr
Regulatory Affairs Manager Company: Huisong Inc. Location: Santa Ana, California, Orange County Schedule: Part-time, approximately 10 hours per week Work Arrangement: On-site About Huisong Inc.
Quick apply
Regulatory Affairs Manager
Santa Ana, CA · On-site
$38 - $48/hr
Regulatory Affairs Manager Company: Huisong Inc. Location: Santa Ana, California, Orange County Schedule: Part-time, approximately 10 hours per week Work Arrangement: On-site About Huisong Inc.
Regulatory Affairs Manager
Santa Clara, CA · On-site
$120K - $145K/yr
Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...
Regulatory Affairs Manager
Santa Clara, CA · On-site
$120K - $145K/yr
Acting as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance ...
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Regulatory Affairs Manager
Sarasota, FL · On-site
$100 - $125/hr
Education Bachelor's degree in Quality, Regulatory Affairs or an applicable science (Engineering ... Risk management (ISO 14971). Clinical evaluation requirements. Change control and post-market ...
New
Regulatory Affairs Manager
Sarasota, FL · On-site
$100 - $125/hr
Education Bachelor's degree in Quality, Regulatory Affairs or an applicable science (Engineering ... Risk management (ISO 14971). Clinical evaluation requirements. Change control and post-market ...
New
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
WI · On-site
$80 - $100/hr
We are looking for a Regulatory Affairs Manager who is experienced, hands‑on, and communicative to join us in our Regulatory Affairs team, based in our EMEA headquarters office in Mechelen, Belgium.
WI · On-site
$80 - $100/hr
We are looking for a Regulatory Affairs Manager who is experienced, hands‑on, and communicative to join us in our Regulatory Affairs team, based in our EMEA headquarters office in Mechelen, Belgium.
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Quick apply
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Regulatory Affairs Manager Duration: 06+ months (Possibility to Hire) Required: The Regulatory ... Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience.
Regulatory Affairs Manager Duration: 06+ months (Possibility to Hire) Required: The Regulatory ... Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience.
Regulatory Affairs Manager
Sturtevant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Regulatory Affairs Manager
Sturtevant, WI · On-site
The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic ...
Regulatory Affairs Manager - IVD
San Diego, CA · On-site
$125 - $150/hr
The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...
Regulatory Affairs Manager - IVD
San Diego, CA · On-site
$125 - $150/hr
The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic ... Bachelor's degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory ...
Regulatory affairs Manager
Lexington, MA · On-site
Direct Client Location Lexington, MA Job Title Regulatory Affairs Manager Duration 6+ Months Must have skill-set [ ] Job Function and Description: Serve as the senior and principal regulatory affairs ...
Regulatory affairs Manager
Lexington, MA · On-site
Direct Client Location Lexington, MA Job Title Regulatory Affairs Manager Duration 6+ Months Must have skill-set [ ] Job Function and Description: Serve as the senior and principal regulatory affairs ...
Regulatory Affairs Manager
Lexington, MA · On-site
Client Direct Client Location Lexington, MA Job Title Regulatory Affairs Manager Duration 6+ Months Must have skill-set [ ] Job Function and Description: Serve as the senior and principal regulatory ...
Regulatory Affairs Manager
Lexington, MA · On-site
Client Direct Client Location Lexington, MA Job Title Regulatory Affairs Manager Duration 6+ Months Must have skill-set [ ] Job Function and Description: Serve as the senior and principal regulatory ...
Regulatory Affairs Manager Engineer information
See salary details
$28.85 - $34.09
4% of jobs
$34.09 - $39.34
19% of jobs
$40.65 is the 25th percentile. Wages below this are outliers.
$39.34 - $44.58
7% of jobs
$44.58 - $49.83
11% of jobs
The median wage is $53.88 / hr.
$49.83 - $55.07
12% of jobs
$55.07 - $60.31
15% of jobs
$64.12 is the 75th percentile. Wages above this are outliers.
$60.31 - $65.56
11% of jobs
$65.56 - $70.80
7% of jobs
$70.80 - $76.05
4% of jobs
$76.05 - $81.29
6% of jobs
$81.29 - $86.54
4% of jobs
$28
$56
$86
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Job description
The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.
Responsibilities:
- Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
- Serve as primary RA contact on project teams to support product development.
- Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
- Respond to FDA queries and deficiencies.
- Provide guidance to RA Associates and aid in development of team.
- Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
- Monitor and interpret new and evolving regulations and assess impact on company products.
- Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
- Oversee adverse event reporting process and ensure compliance with reporting requirements.
- Support due diligence activities, licensing, and partnerships.
- Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
- 5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred
- Highly detail-oriented and possess considerable problem-solving and organization skills
- Ability to work on complex projects and take initiative with general direction and minimal guidance
- Ability to be flexible with a change in priorities
- Excellent written, verbal, and listening skills, must work well with others
- Experience using an electronic document control system
- Experience with eCTD publishing software preferred
- Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
About Ritedose
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Columbia, SC, US
Year founded
1995