15 Regulatory Affairs Manager Jobs in Rockville, MD
System One is Hiring a Regulatory Affairs Manager Near Rockville, MD
Location: Remote
Type: Permanent Salary: 120K – 140K plus 10-20% discretionary bonus
Requirements
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Minimum of 3-5 years of experience in operational regulatory affairs within the biotech, preferably in oncology.
- Writing Canadian and US submissions (BGTD experience)
- eCTD experience required (package used is off the shelf product)
- Strong knowledge of global regulatory requirements and guidelines for drug development.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- Proven ability to manage multiple projects simultaneously and meet tight deadlines.
- Detail-oriented with a strategic mindset and problem-solving skills.
- Develop and implement regulatory strategies to support the development and commercialization of oncology products.
- Prepare and submit regulatory submissions to health authorities, including INDs, CTAs, NDAs, and marketing applications.
- Coordinate and liaise with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
- Keep abreast of regulatory changes and updates relevant to the oncology industry, providing guidance to internal stakeholders.
- Represent the company in interactions with regulatory agencies and support regulatory inspections and audits.
- Manage regulatory documentation and maintain compliance with applicable regulations and standards.
Job Summary
Other
Business Services
$139k-185k (estimate)
02/23/2024
05/21/2024
healthsystemone.com
MIAMI, FL
25 - 50
Private
JOSEPH BRUCE
$10M - $50M
Business Services
Related Companies
The job skills required for Regulatory Affairs Manager include Regulatory Affairs, Problem Solving, Regulatory Compliance, Oncology, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Manager positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Manager, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Manager. You can explore the career advancement for a Regulatory Affairs Manager below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Affairs Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Affairs Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Affairs Manager job description and responsibilities
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
04/15/2022: Charleston, SC
They will provide responses to regulatory agencies regarding product information or issues.
04/10/2022: Charleston, SC
They'll establish regulatory priorities or budgets and allocate resources and workloads.
02/22/2022: Temple, TX
Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies.
02/15/2022: Harlingen, TX
The position will provide regulatory review, registration and data management, strategic regulatory advice and submissions to appropriate regulatory agencies.
05/09/2022: New Brunswick, NJ
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Affairs Manager jobs
Having the knowledge and understanding of complex medical and scientific subject matter would give you advantage for this role.
03/10/2022: Springfield, OR
You need the ability to build networks to obtain cooperation.
03/12/2022: Temple, TX
Manager Regulatory Affairs are able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
04/10/2022: Great Falls, MT
They utilize their technical skills to ensure products remain safe and efficient by meeting all the regulatory standards.
03/28/2022: Lowell, MA
You need to have IT skills, particularly in relation to using databases and familiarity with commercial software to qualify for this role.
03/28/2022: Anchorage, AK
Step 3: View the best colleges and universities for Regulatory Affairs Manager.
