- Interact with cross functional teams for procurement of documentation required for regulatory submissions
- Review technical documents for accuracy and with supervision, determines acceptability for use in regulatory submissions
- Create documents in accordance with eCTD specifications
- Update and maintain the internal database as needed
- Comply with FDA guidelines/Company Policies of Data Integrity
- Other duties as required or delegated
- At least 1 year experience with technical writing preferred
- Minimum 3 years Pharma experience preferred
- Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills
- Continuous working knowledge of applicable FDA/ICH/DEA regulations
- Continuous working knowledge of applicable cGMP guidelines
-
Regulatory Associate
6 days ago
KVK Tech Newtown, United StatesJob Description · Job DescriptionDepartment: Regulatory Affairs · Job Title: Regulatory Associate · 1. Role Purpose: · Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP req ...
-
Regulatory Associate
1 week ago
KVK Tech, Inc. Newtown, United States**Department**:Regulatory Affairs · **Job Title**:Regulatory Associate · **1. Role Purpose**: · Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, E ...
-
Corporate Associate
4 weeks ago
Insite Legal Ltd Hartford, United StatesA premier Connecticut based mid-size law firm are seeking mid to senior level Associates to join their Corporate practice group. · They are seeking a highly skilled and motivated Attorney to join their Corporate Practice Group. The successful candidate will play a crucial role in ...
-
Senior Engineer, ISO Policy
3 weeks ago
Eversource Energy Hartford, United States RegularEssential Functions · : Performs engineering power flow, economic capacity expansion, production cost, and probabilistic modeling analyses of the New England system. Oversees consultants who may be retained to perform technical analysis. Performs technical studies independently ...
-
Compliance Specialist
2 days ago
Deringer-Ney Inc. Hartford, United StatesTitle: Compliance Specialist · Job Summary: · Oversee compliance requests and requirements to ensure that statutory, regulatory, and customer specific requirements are met (i.e., Export Controls/ITAR, FARs, DFARs, REACH, RoHS, Conflict Minerals/CMRT, FDA, etc.). Support and/or dr ...
-
Principal Consultant, Corporate Sustainability
3 weeks ago
ERM Hartford, United States Full timeERM is seeking a Principal Consultant, Corporate Sustainability & Climate Change to join our growing corporate sustainability and climate change advisory services practice in one of our offices across North America. · In this role, you will be a key contributor to a team devel ...
-
Associate Medical Director
2 weeks ago
Hartford-GoHealth Urgent Care Hartford, United StatesWe're looking for a second Associate Medical Director (MD/DO) to join our welcoming and diverse community of Providers. This is a 50% clinical, 50% admin position. · The Associate Medical Director (AMD) assists in the managing and directing of all clinical services and is primar ...
-
State of Connecticut Hartford, United StatesIntroduction · Connecticut prioritizes appointing highly qualified residents who reflect the state's great diversity to our critically important boards and commissions. · For the appointments that the Department of Energy and Environmental Protection (DEEP) makes or recommends, ...
-
Sr Analyst, Product Rating
3 weeks ago
Travelers Hartford, United States Full timeWho Are We? · Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 160 years. Join us to discover a cultu ...
-
Accounting Manager
3 weeks ago
Mohegan PA Hartford, United StatesAccounting Manager - Non-Gaming page is loaded · Accounting Manager - Non-Gaming · Apply · locations · Uncasville, CT · time type · Full time · posted on · Posted Yesterday · job requisition id · R-01893 · JOIN OUR TEAM AND EXPERIENCE ENDLESS CAREER POSSIBILITIESIF YOU ...
-
Forklift Operator
6 days ago
Coca-Cola Northeast East Hartford, United StatesCompensation: $21.80 an hour · Schedule: Monday - Friday, 10:30pm - 7am. · Why Join Coke Northeast? · Culture - At Coca-Cola Beverages Northeast, we deliver more than your favorite beverages. We deliver on a promise – to live our values by investing in our people, focusing on ou ...
-
Insurance Accredited Financial Examiner(Hybrid)
4 weeks ago
State of Connecticut Hartford, United StatesIntroduction · The , Connecticut Insurance Department , is currently recruiting for an position, with the Department of Insurance, Field Financial Examination Unit. WHAT WE CAN CONTINUE TO OFFER YOU Competitive starting salary · A Platinum Healthcare Plan, the nation's best fo ...
-
Oracle Cerner Healthcare Project Manager
3 weeks ago
UnitedHealth Group Hartford, United States Full timeOptum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel ...
-
Medical Assistant--Hartford
3 days ago
Community Health Center Hartford, United StatesJob Description Summary: · Job Description: · **Full Time Opportunity, Monday- Friday with one Saturday per month, Compensation at $21 per hour plus healthcare benefits** · On a daily basis, provides clinical and technical support for primary care providers. Implements all planne ...
-
State of Connecticut Hartford, United StatesIntroduction · The Department of Banking is recruiting for a with the WHAT WE CAN OFFER YOU Competitive starting salary · A culture that encourages · Working for a Forbes top company: - State of CT Receives National Recognition for Offering Job Growth, Competitive Benefits, a ...
-
Legislative and Regulations Specialist(Hybrid)
3 weeks ago
State of Connecticut Hartford, United StatesIntroduction · The, Department of Consumer Protection () is accepting applications for a in Hartford, CT. WE CAN OFFER YOU: · Visit our new page · The opportunity to work for a Forbes top company: 'Forbes' - State of CT Receives National Recognition for Offering Job Growth, ...
-
Exec Admin Asst II
1 week ago
TD Bank, N.A. Hartford, United States Full timeDescription · : The Executive Administrative Assistant II provides highly skilled, diversified, confidential, and administrative support of an executive nature to a senior executive of a Company division, performing complex and technical activities requiring considerable discret ...
-
020 Travelers Indemnity Co Hartford, United States Full timeWho Are We? · Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 160 years. Join us to discover a cultu ...
-
Affordable Housing Originator
3 days ago
NBT Bancorp Inc. West Hartford, United States Full timeAssists in the development, implementation, and reporting of CRA-related loan tracking, loan programs and all activities designed to maintain a high satisfactory rating for NBT Bank, N. A. with the Community Reinvestment Act. Assists with coordination and compilation of Residenti ...
-
Regulatory Affairs Specialist
3 weeks ago
Onsite Personnel LLC Newtown, United StatesJob Description · Job DescriptionOverview: Regulatory Associate:Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA. · Key Duties & Resp ...
Regulatory Associate - Newtown, United States - KVK Tech
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Job Description
Job DescriptionDepartment: Regulatory Affairs
Job Title: Regulatory Associate
1. Role Purpose:
Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.
2. Key Duties & Responsibilities:
3. Typical Supervisory Responsibility:
N/A
4. Education & Experience:
Bachelor's Degree in Pharmacy, Chemistry or Scientific Discipline preferred
5. Technical competencies/ Certifications/ Licenses:
6. Physical demand and Work environment:
a. Physical demands:
While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.
b. Work environment:
N/A