Senior Associate, Regulatory Affairs CMC
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
- Job Profile SummaryDevelops and implements global chemistry manufacturing and control (CMC) regulatory strategies throughout the lifecycle of biologics pharmaceuticals and devices. Prepares and directs the development of CMC submissions including initial market registrations progress reports supplements amendments and/or periodic experience reports. Represents company during communications and meetings with health authorities. Interacts and negotiates with regulatory agencies in order to expedite approval of pending registration and answer any questions. Participates in identification of risk areas and develops alternative courses of action. Assesses impact of new regulations and implements appropriate changes leads development of company policy and positions on draft regulations and guidance.
- Job Description
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us
This role is part of Alcons Quality & Regulatory Affairs function a team that ensures our products are in compliance with global local and internal regulations and meet the strictest standards of quality as we help people see Sr. Associate Chemistry Manufacturing & Control (CMC) (Professional Path) is primarily responsible for supporting global CMC regulatory strategies and maintenance for biologics pharmaceuticals and devices. You will assist in preparing CMC submissions support product registration preparation and support and manage maintenance activities of approved products. Youll also identify regulatory risks develop alternative solutions and assess new regulations for necessary changes.
Specifics Include:
Support and manage registration maintenance activities for the approved productsAssist in developing and implementing global CMC regulatory strategies for biologics pharmaceuticals and devices
Help prepare CMC submissions including market registrations progress reports annual reports supplements amendments and periodic experience reports
Participate in identifying risk areas and developing alternative courses of action
Assess the impact of new regulations and implement necessary changes
Adhere to GxP regulations by following SOPs maintaining accurate documentation ensuring quality control and completing required training
Meet individual job requirements and contribute to overall organizational compliance and continuous improvement with regulatory requirements
Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.Employment scams: Alcon is aware of employment scams which make false use of our company name or leaders names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website where you can search for open positions and apply directly.
If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent we strongly recommend you do not respond send money or personal information and check our website for current job openings.
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If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital status disability or any other reason.
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
