Top Regulatory Affairs Executive jobs in Ventura, CA
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
Associate Regulatory Affairs - (JP9887)
- 3 Key Consulting
-
Thousand Oaks, CA
FULL_TIME
-
Job Title: Associate Regulatory Affairs - (JP9887)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: CMC Core Team A
Duration: 1 years (with likely extensions)
Notes: Onsite opportunity - Thousand Oaks, CA
Posting Date: 03/09/2022
3 Key Consulting is hiring an Associate Regulatory Affairs CMC for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing, and executing on regulatory CMC projects in support of regulatory submissions. Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested. What we are looking for:- Desire to learn Regulatory Affairs CMC and global submission strategy;
- Strong organizational skills with attention to detail;
- Proficient time management skills and ability prioritize workload;
- Ability to work both independently and as a member of a team;
- Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
- Qualified to work in the U.S. without employer sponsorship;
- Commitment of a 40-hour work week in Thousand Oaks,
Why is the Position Open?
Supplement additional workload on team
Top Must-Have Skill Sets:- Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude (client is a very large organization and there will be many parties the candidate will need to engage with for project success).
- Being Comfortable With Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
- Attention to Detail – Ideal candidate will be thorough and deliver polished work product.
Day to Day Responsibilities:
Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development.
Basic Qualifications:- Experience o Bachelor’s or Master's degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience, OR
- Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience, OR
- High school diploma / GED and 8 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience.
Preferred Qualifications:- Degree in life sciences, biochemistry, or chemistry.
- Experience in biopharmaceutical or pharmaceutical industry.
- Familiarity with eCTD structure.
- Motivated with initiative to learn quickly.
- Experience in CMC, including preparation of submissions to Agencies.
- Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint.
Red Flags:- Leaving assignments before projects are complete.
- Unexplainable time gaps in resumes.
- References that are not from recent employers.
- References that are not direct supervisors.
Interview process:
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
- 18 Days Ago
Regulatory Affairs Senior Associate
- Advanced Bio-Logic Solutions Corp
-
Thousand Oaks, CA
FULL_TIME
- Top 3 Must Have Skill Sets: Knowledge of FDA Knowledge of Good Regulatory Practices/Good Clinical Practice Use of regulatory information management systems Day to Day Responsibilities: Coordination an...
- 18 Days Ago
Regulatory Affairs Associate
- Actalent
-
Newbury, CA
FULL_TIME
- JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.) ESSENTIAL DUTIES:Independently plan, prepare, coordi...
- 2 Days Ago
Sr. Regulatory Affairs Associate
- Actalent
-
Newbury, CA
FULL_TIME
- JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.) ESSENTIAL DUTIES:Independently plan, prepare, coordi...
- 2 Days Ago
Associate Regulatory Affairs
- Advanced Bio-Logic Solutions Corp
-
Thousand Oaks, CA
FULL_TIME
- Top 3 Must Have Skill Sets: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceut...
- 8 Days Ago
Regulatory Affairs Manager
- Advanced Bio-Logic Solutions Corp
-
Thousand Oaks, CA
FULL_TIME
- Description: Note: 100% REMOTE - Needs to support PST time zone (flexible), must support ATO site hours Need someone to can hit the ground running Ideal candidate: someone with a mixed background not ...
- 8 Days Ago
Filters
- Current Active Filter
- Ventura, CA
Clear All
- Filter Jobs By posted time
- Within 1 Day
- Within 2-7
- Within 1 Month
- Within 3 Months
0 Top Regulatory Affairs Executive jobs found in Ventura, CA area
Transportation Environmental Planner/Scientist
- Rincon Consultants
-
Ventura, CA
- Rincon Consultants is seeking an Environmental Planner/Scientist with experience in transportation (roadway, transit, ra...
- 4/24/2024 12:00:00 AM
Principal Engineer
- Bausch + Lomb
-
Ventura, CA
- Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of ...
- 4/24/2024 12:00:00 AM
Primary Care Clinic Senior Registered Nurse
- County of Ventura (CA)
-
Ventura, CA
- Description What We Offer The County of Ventura offers an attractive compensation and benefits package, subject to eligi...
- 4/24/2024 12:00:00 AM
Clinical Educator LVN
- CommonSpirit Health
-
Ventura, CA
- Overview: Dignity Health Medical Foundation established in 1993 is a California nonprofit public benefit corporation wit...
- 4/24/2024 12:00:00 AM
Licensed Therapist
- Pinnacle Treatment Centers
-
Ventura, CA
- Overview: We offer competitive salary, full benefits package, Paid Time Off, and opportunities for professional growth. ...
- 4/23/2024 12:00:00 AM
Climate Adaptation and Resilience Planner/ Project Manager
- Rincon Consultants
-
Ventura, CA
- Rincon Consultants, Inc. is seeking an experienced Climate Adaptation and Resilience Planner/Project Manager who will co...
- 4/23/2024 12:00:00 AM
AVP, Risk Management
- VENTURA COUNTY CREDIT UNION
-
Ventura, CA
- Job Details Job Location OCEAN VIEW - Ventura, CA Position Type Full Time Salary Range $129,170.00 - $161,462.00 Salary ...
- 4/22/2024 12:00:00 AM
Rev Cycle Operational Analyst
- Luminous Technology Group
-
Ventura, CA
- Company Description Job Description This position requires 2-3 days on-site per week in Ventura. Job Summary: The Revenu...
- 4/22/2024 12:00:00 AM
About Ventura, California
Ventura is located northwest of Los Angeles on the California coast. The western portion of the city stretches north along the Ventura River and is characterized by a narrow valley with steeply sloped areas along both sides. The steep slopes of the Ventura foothills abut the northern portion of the community. Much of the eastern portion is on a relatively flat alluvial coastal plain lying along the western edge of the Oxnard Plain. The Santa Clara River forms the city's southerly boundary with the city limits reaching up to the beginning of the Santa Clara River Valley at the historic communit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$314,009 to $513,727
Ventura, California area prices
were up 2.5% from a year ago
were up 2.5% from a year ago
What does a Top Regulatory Affairs Executive do?
Top Regulatory Affairs Executive in Santa Ana, CA
Based on our compensation data, the estimated salary potential for Top Regulatory Affairs Executive will increase 16 % over 5 years.
February 05, 2020
Top Regulatory Affairs Executive in Wilmington, DE
ERI Economic Research Institute compiles the best salary, cost-of-living, and executive compensation survey data available.
February 01, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020