Regulatory Affairs Manager

Lawrence Harvey


Job ID :

10247


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--California,San Diego,


Key Skills :

Regulatory Affairs NDA IND BLA MAA eCTD


Salary :

Negotiable


Date Posted :

29 Jan, 2018



Company Name :

Lawrence Harvey


Location1 :

San Diego




Job Category :

Biotech Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

San Diego

Regulatory Affairs Manager

SciPro Global have been engaged by one of our key clients in Southern California, a biotech company, in finding Regulatory Affairs manager to join their growing Regulatory Affairs team. Working as part of the team you will take part in the developing of regulatory strategies, planning, managing & executing regulatory activities.

As the Regulatory Affairs Manager you will need to demonstrate strong knowledge of pharma/biotech FDA submissions skills and a drive for results that are needed to achieve company objectives in accord with client's culture and core values.

Role & Responsibilities:

* Support the executive team to develop US regulatory strategies and work with the global regulatory team towards the development of global regulatory strategies
* Provide strategic input to the global Regulatory team for all US-based Regulatory Affairs matters, including the seeking of Scientific Advice
* Define and execute strategies for regulatory submissions for INDs/ NDAs/BLAs and required maintenance (amendments, notifications, supplements, renewals, annual updates) for drug products in the US & internationally
* eCTD submission experience would be highly preferred but not necessary
* CMC regulatory submissions experience is a strong plus
* Manage customization of IND dossiers, and organize submission and registration of drug products in a professional, compliant, and timely manner
* Support the writing and review of SOPs and assist in inspection readiness programs
* Serve as a representative of the client to the US regulatory community; serve as a liaison with the FDA to support effective professional and company relationships
* Educate project teams on regulatory pathways and requirements to ensure effective product development and registration
* Maintain an effective archiving system
* Ensure that the pharmaceutical products distributed in the US meet FDA requirements and support the local commercial organizations
* In partnership with other regulatory staff, maintain and expand current knowledge of regional regulatory requirements and precedents that may affect the clinical development and commercialization of company products
* Support contractor selection and coordination of contracted activities

Qualifications:

* Masters or Bachelor's degree, preferably in life sciences
* Minimum of 5 years of Regulatory experience
* CMC regulatory submission experience a plus but not required
* eCTD experience highly preferred

If you are looking to join an open and collaborative team who are keen on your development to gain not only national but also international experience within the Regulatory Affairs space, then this could be for you.

If you would like to learn more about this position, please apply directly or feel free to send me your contact details/ updated resume to p.bullaj@sciproglobal.com for more information.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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