Regulatory Affairs Specialist jobs in Lancaster, CA
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Principal Regulatory Affairs Specialist
- Kindeva Drug Delivery
-
Los Angeles, CA
FULL_TIME
- Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. ROLE SUMMARY Seeking a Principal Regulatory Affairs Specialist to support the Kindeva business in maintaining regulatory compliance of existing manufactured products for customers on a global basis by: Managing regulatory compliance activities for Kindeva and existing customer products and registrations as required and providing strategic planning for regulatory changes. Acting as the regulatory lead for site-specific activities (e.g., Quality Reviews, Change Committees, etc.) Co-ordinating and preparing regulatory documentation for clinical trial applications, Drug Master Files (DMFs), medical device technical documentation and registration CTD documents (where required). Managing or mentoring more junior staff as required to achieve the business and role goals and objectives. ROLE RESPONSIBILITIES Management and Mentoring (Approx. 10-20% of time): Providing input and direction to the site and wider Kindeva business on regulatory matters. Providing regulatory support to team members as required on specific project issues ensuring alignment with global guidelines and legislation and the specific business needs of Kindeva Managing and/or mentoring members of the regulatory team as required. Marketed Product and Manufacturing Site Support Duties and Responsibilities (Approx. 60 – 80% of Time): Advising internal and external stakeholders of the likely regulatory requirements associated with planned and unplanned changes made within the site and broader Kindeva organization. Participating in technical reviews of data within technical teams to ensure alignment with current global guidelines and to ensure data is generated to meet regulatory needs, responding to regulatory questions from wider technical teams. Managing regulatory authority meetings as required including preparing briefing documentation and presentations. Membership of project teams, including estimating regulatory resource needs for incorporation into project plans and monitoring of regulatory activities versus the project plan; reporting of issues / delays to management. Attending customer focused meetings and interfacing with identified regulatory contacts at the customer company including preparing and reviewing presentations. Communication of regulatory learnings from other projects. E.g., IND feedback, MAA project feedback, Pre IND meeting outcomes to ensure continuous improvement. Advising on CMC elements of variation / supplement packages as required. Communicating expectations of approval timelines within the organization. Other Duties and Responsibilities (Approx. 10-20% of Time): Providing regulatory leadership for site-specific activities Monitoring the developing and evolving global regulatory guidelines which impact the development and maintenance of medicinal products and providing assessments of the implications of the proposed legislation. Recruiting, training, mentoring, motivating, and developing the team. Coaching and encouraging staff to be self-sufficient, to work actively with other departments and to become expert in their fields and where appropriate, to be active key members of project teams. Ensuring continued personal development, identifying gaps, learning through doing and maintaining current knowledge of requirements for the role. (Note: Percentages of time spent on job duties are estimates and may vary for each individual depending on experience and knowledge and current business requirements) BASIC QUALIFICATIONS Education: Graduate in pharmacy or a life science (or equivalent). Additional regulatory qualifications advantageous. Experience: 7 years relevant experience of US, European or Global registration procedures (or significant experience in other areas of the pharmaceutical industry). Knowledge: In-depth knowledge of the Global Regulatory Affairs environment – Guidelines and legislation. Deep practical knowledge of the drug regulatory processes in the US and background understanding of regulatory processes in other regions. General understanding of drug development and pharmaceutical manufacturing from concept to launch including requirements for product development, manufacturing and marketing and the impact of regulatory changes on business goals/objectives. · Broad understanding of the pharmaceutical business in general and of other relevant associated regulatory areas (e.g., Clinical Affairs, Medical Devices, Chemicals Regulations, etc.). Key Capabilities: Able to communicate effectively orally and in writing. Able to work both as part of a cross-functional team but also act independently. · Enthusiastic and determined to achieve set objectives. Comfortable working with detailed technical information but also able to see the overall picture. Possess strong computer skills and excellent organizational capabilities. Demonstrate flexibility, strategic thinking and drive to succeed. Be able to deliver results accurately within demanding time frames. Able to handle a crisis in a professional and positive manner. Able to communicate effectively with colleagues at all levels.
- 5 Days Ago
Regulatory Affairs Specialist
- PureTek Corporation
-
Panorama, CA
FULL_TIME
- We are currently seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be pivotal in ensuring compliance with regu...
- 6 Days Ago
Principal Specialist, Regulatory Affairs
- Advanced Bionics, LLC
-
Valencia, CA
FULL_TIME
- Who we areYou enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: We...
- 19 Days Ago
Principal Regulatory Affairs Specialist
- Kindeva Drug Delivery Careers
-
Los Angeles, CA
FULL_TIME
- Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our cus...
- 20 Days Ago
Principal Specialist, Regulatory Affairs
- Sonova
-
Valencia, CA
FULL_TIME
- Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: W...
- 22 Days Ago
Regulatory Affairs Specialist II
- City of Hope
-
Duarte, CA
FULL_TIME
- Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and othe...
- 25 Days Ago
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0 Regulatory Affairs Specialist jobs found in Lancaster, CA area
Portfolio Manager
- Shuster Advisory Group, LLC
-
Pasadena, CA
- Job Description Job Description Shuster Advisory Group, LLC is seeking an experienced portfolio manager who can add a fr...
- 4/18/2024 12:00:00 AM
Compliance Supervisor
- Ultimate Staffing
-
Burbank, CA
- We are seeking an innovative Supervisor to join our team. The Supervisor is responsible for overseeing the daily activit...
- 4/18/2024 12:00:00 AM
Compliance Consultant III, Medical Coding Information Technology
- Kaiser Permanente
-
Pasadena, CA
- Description: Job Summary: In addition to the responsibilities listed below, the position is responsible for serving as a...
- 4/18/2024 12:00:00 AM
Financial analyst jr.
- Randstad
-
Los Angeles, CA
- Our client is a leading healthcare company with an immediate need for a skilled and experienced Financial Analyst Jr. in...
- 4/18/2024 12:00:00 AM
Financial Analyst - Jr
- Artech LLC
-
Los Angeles, CA
- Perform accounting, reporting and financial analysis as assigned for the enterprise. This role is responsible for comple...
- 4/18/2024 12:00:00 AM
Investment Consultant - Pasadena, CA
- Fidelity TalentSource LLC
-
Pasadena, CA
- Job Description: Investment Consultant You joined the financial services industry to make a difference in the lives of y...
- 4/17/2024 12:00:00 AM
PA/NP
- Crawford Thomas Recruiting
-
Palmdale, CA
- Job Title: Physician Assistant (PA) / Nurse Practitioner (NP) Salary Range: $100k - 140k Our client is committed to prov...
- 4/16/2024 12:00:00 AM
Compliance Supervisor
- Ultimate Staffing
-
Burbank, CA
- We are seeking an innovative Supervisor to join our team. The Supervisor is responsible for overseeing the daily activit...
- 4/15/2024 12:00:00 AM
About Lancaster, California
Lancaster /ˈlæn.kæstər/ is a charter city in northern Los Angeles County, in the Antelope Valley of the western Mojave Desert in Southern California. As of 2013, Lancaster was the 31st largest city in California. Lancaster is part of a twin city complex with its southern neighbor Palmdale and together they are the principal cities within the Antelope Valley region.
Lancaster is located approximately 61 miles (98 km) north (by highway) of downtown Los Angeles, near the Kern County line. It is separated from the Los Angeles Basin by the San Gabriel Mountains to the south, and from Bakersfield a...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$84,157 to $112,784
Lancaster, California area prices
were up 3.2% from a year ago
were up 3.2% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020