Regulatory Affairs Pharma and Device
3 weeks ago
Must be able to show proof of citizenship.
***NOTE If this opportunity interests you, please share a WORD resume that details your exp related to the job responsibilities and requirements.
Excellent opportunity to advance and grow your career with an Industry leader. Position offers excellent comp, bonus and benefits.
Don't miss out
Scope
To support business in maintaining regulatory compliance of existing manufactured products for customers on a global basis.
- Managing regulatory compliance activities 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.
Management and Mentoring (Approx. 10-20% of time):
• Providing input and direction to the site on client's 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 the client
• 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 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
Requirements
• Graduate in pharmacy or a life science (or equivalent).
• Solid and relevant experience of US, European or Global registration procedures (or significant experience in other areas of the pharmaceutical industry).
• 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.).
#J-18808-Ljbffr
-
Regulatory Affairs Pharma and Device
3 weeks ago
Los Angeles, United States Medvacon Life Sciences Full timeNO AGENCIES! - pl do not submit.Must be able to show proof of citizenship.***NOTE If this opportunity interests you, please share a WORD resume that details your exp related to the job responsibilities and requirements.Excellent opportunity to advance and grow your career with an Industry leader. Position offers excellent comp, bonus and benefits.Don't miss...
-
Regulatory Affairs Pharma and Device
3 weeks ago
Los Angeles, United States Medvacon Life Sciences Full timeJob DescriptionJob DescriptionNO AGENCIES! - pl do not submit.Must be able to show proof of citizenship.***NOTE If this opportunity interests you, please share a WORD resume that details your exp related to the job responsibilities and requirements.Excellent opportunity to advance and grow your career with an Industry leader. Position offers excellent...
-
Regulatory Affairs Pharma
7 days ago
Los Angeles, United States MEDVACON TALENT ACQUISITION, LLC Full timeNO AGENCIES! - pl do not submit.W2 candidates only***NOTE If this opportunity interests you, please share a WORD resume that details your exp related to the job responsibilities and requirements.ScopeTo support business in maintaining regulatory compliance of existing manufactured products for customers on a global basis.Managing regulatory compliance...
-
Regulatory Affairs Pharma
1 month ago
Los Angeles, United States MEDVACON TALENT ACQUISITION, LLC Full timeNO AGENCIES! - pl do not submit.W2 candidates only***NOTE If this opportunity interests you, please share a WORD resume that details your exp related to the job responsibilities and requirements.ScopeTo support business in maintaining regulatory compliance of existing manufactured products for customers on a global basis.Managing regulatory compliance...
-
Regulatory Affairs Pharma
7 days ago
Los Angeles, United States Medvacon Talent Acquisition Llc Full timeNO AGENCIES! - pl do not submit. W2 candidates only ***NOTE If this opportunity interests you, please share a WORD resume that details your exp related to the job responsibilities and requirements. Scope To support business in maintaining regulatory compliance of existing manufactured products for customers on a global basis. Managing regulatory compliance...
-
Regulatory Affairs Associate
4 days ago
Los Angeles, United States Apex Systems Full timeClient: IRIDEX Position: Regulatory Affairs Associate Location: Mountain View, CA Contract Length: 5 months Pay Range: $35 - $45/hr IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, Health Canada SOR/ 98-282, and the...
-
Regulatory Affairs Specialist
4 weeks ago
Los Angeles, United States BioTalent Full timePosition Summary The primary responsibility of the Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The RAS is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for our client's product...
-
Regulatory Affairs Coordinator
2 days ago
Los Angeles, United States ProKatchers Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill Coordinator Location: 91342, Los Angeles, California, United States Duration: 06 Month Job Description: This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer...
-
Regulatory Affairs Coordinator
4 weeks ago
Los Angeles, United States ProKatchers LLC Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill CoordinatorLocation: 91342, Los Angeles, California, United StatesDuration: 06 MonthJob Description:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person...
-
Regulatory Affairs Coordinator
4 weeks ago
Los Angeles, United States ProKatchers Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill Coordinator Location: 91342, Los Angeles, California, United States Duration: 06 Month Job Description: This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. ...
-
Regulatory Affairs Coordinator
4 weeks ago
Los Angeles, United States ProKatchers LLC Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill CoordinatorLocation: 91342, Los Angeles, California, United StatesDuration: 06 MonthJob Description:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person...
-
Regulatory Affairs Coordinator
4 weeks ago
Los Angeles, United States ProKatchers LLC Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill CoordinatorLocation: 91342, Los Angeles, California, United StatesDuration: 06 MonthJob Description:This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person...
-
Regulatory Affairs Coordinator
3 weeks ago
Los Angeles, United States ProKatchers Full timeJob Title: Regulatory Affairs Coordinator/Regulatory Windchill Coordinator Location: 91342, Los Angeles, California, United States Duration: 06 Month Job Description: This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. ...
-
Regulatory Affairs manager
4 weeks ago
Los Angeles, United States Kindeva Drug Delivery Company Full time19901 Nordhoff St, Northridge, CA 91324, USA Job Description Posted Tuesday, March 19, 2024 at 4:00 AM K indeva 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....
-
Regulatory Affairs Specialist
4 weeks ago
Los Angeles, United States PureTek Full timeJob Description Job Description PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well-being and beauty of our consumers. Join our team and contribute to our mission of...
-
AD/Director Regulatory Affairs
4 weeks ago
Los Angeles, United States Meet Full timeMeets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's rare...
-
Regulatory Affairs Specialist
2 weeks ago
Los Angeles, United States PureTek Corp Full timeJob DescriptionJob Description PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well-being and beauty of our consumers. Join our team and contribute to our mission of...
-
Regulatory Affairs Manager
6 days ago
Los Angeles, United States JSHealth Vitamins Full timeJSHealth Vitamins is seeking a Regulatory Affairs Manager to join our dynamic team in Westwood, Los Angeles. We are a leading science-focused vitamin and wellness brand that provides targeted formulas to help customers meet their personal health goals. Our founder, Jessica Sepel, is a best-selling health author who founded JSHealth Vitamins to provide her...
-
Regulatory Affairs Manager
6 days ago
Los Angeles, United States JSHealth Vitamins Full timeJSHealth Vitamins is seeking a Regulatory Affairs Manager to join our dynamic team in Westwood, Los Angeles. We are a leading science-focused vitamin and wellness brand that provides targeted formulas to help customers meet their personal health goals. Our founder, Jessica Sepel, is a best-selling health author who founded JSHealth Vitamins to provide her...
-
Manager, Regulatory Affairs
2 days ago
Los Angeles, United States L.A. Care Health Plan Full timeSalary Range: $102,183.00 (Min.) - $132,838.00 (Mid.) - $163,492.00 (Max.)Established in 1997, L.A. Care Health Plan is an independent public agency created by the state of California to provide health coverage to low-income Los Angeles County residents. We are the nation’s largest publicly operated health plan. Serving more than 2 million members...
