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Regulatory Affairs Director - **FDA Biologics Experience**, London

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Location:

London, United Kingdom 

Job Category:

Healthcare

Salary:

€90,000.00 - €100,000.00

EU work permit required:

Yes
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Job Reference:

RADIrect_002_1622817687

Job Views:

42

Posted:

04.06.2021

Expiry Date:

19.07.2021
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Job Description:

RA Director – **FDA & Biologics Experience** - Career Progression

Are you a Regulatory Affairs professional within Medical Devices with FDA experience?

Do you have a scientific background with knowledge of biologics and semi-solid formulations?

If you can answer ‘yes’ then you have come to the right place! Get ready to embark on a highly rewarding, remunerative and challenging role as RA Director for an established-company seeking FDA approval and US market share.

My client is one of the best regarded medical devices companies in the world. You will be directly providing the CEO with strategic direction to lead the company, leading a team and directly cooperating with the FDA regarding the company’s wound managements gels.

Ideally Belgium based, but Germany, Netherlands or Luxembourg also OK.

Working for an rapidly growing company on the edge of mass expansion will provide you with a multitude of options for personal & professional growth, career development and progression opportunities.



Your responsibilities will include but not be limited to:

* Compliance with workplace policies and procedures for risk identification, assessment and control.
* Active participation in activities associated with the management of workplace health and safety
* Identification and reporting of health and safety risks, accidents, incidents, injuries and property damage at the workplace
* Correct utilization of appropriate personal protective equipment.
* Responsible for product registration submissions, such as, FDA submissions, EU notified body submissions and other regulatory documents in collaboration with quality department where needed.
* Advise in market access strategies and Pharmacoeconomics.
* Responsible for compliance with the ethical codes of conduct and of transparency guidelines related to products and fields of activity integrating ethical codes from legislative bodies and vision on ethical conduct in collaboration with HR.
* Develop and implement regulatory strategies that ensure that products, procedures and policies meet and continue to meet applicable regulations in the countries where the company commercializes its products.
* Serve as an internal resource to address and resolve any questions or issues of a regulatory nature.
* Responsible for reimbursement files in close collaboration with the Sales/Marketing department
* Vigilance: investigation of vigilance cases and reporting to the relevant authorities according to applicable legislation and company SOPs
* Responsible for Regulatory Compliance





Your profile:

* University degree in pharmacy or other healthcare related university degree combined with relevant knowledge in biologics and semi-solid formulations through experience”
* Experience in FDA
* Ideally FDA approval experience for biologics because is with center of biologicals. Or experience with topical drugs or semi-solids and knowledge of biologics process
* Combination of RA in pharma + medical devices is required.
* Scientific background is needed - pharma, biology, chemistry, biotechnology,...
* Experience needed in Medical Device Directive
* Leadership skills and people management experience preferred
* Needs to be someone who wants to do both hands-on work and strategic. You will need to contact FDA themselves and write texts for FDA approval.
* Fluent level of English

**Applications are open NOW!!**



If you believe you’re up to this task then I want to hear from you! Do not wait to embark on the next stage of your professional life! Get in contact with Alasdair Wates by submitting your CV in WORD format to a.wates@nonstop-recruitment.com. Feel free to call me on 0044 207 940 2105 ext. 3356.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe.

Please visit our website for a full list of the niche markets we cover or alternately add me on LinkedIn: https://www.linkedin.com/in/alasdair-wates/
Company Info
NonStop Consulting
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site: www.nonstopconsulting.com
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