Director Regulatory Affairs

Lawrence Harvey


Job ID :

15336


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

PhD


Address 1 :

North America,--California,California,


Key Skills :

Regulatory Affairs development, FDA EMA approval, global strategies, regulatory guidelines, cross-fu


Salary :

Negotiable


Date Posted :

30 Sep, 2019



Company Name :

Lawrence Harvey


Location1 :

California




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Director, Regulatory Affairs

United States - California

SciPro is a premier sourcing and advising agency that specializes in connecting highly-skilled life sciences professionals to robust business clients across the globe. Our client is looking for a Director of Regulatory Affairs in an exciting product-facing role in California.



Job Description

Director, Regulatory Affairs will provide regulatory leadership to support the development of new and current programs. This includes the implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance. This person represents the regulatory function on multi-disciplinary teams and will integrate company goals into the objectives and activities of the department. Global Regulatory Affairs is responsible for developing innovative global/regional regulatory strategies to advance novel medicinal oncology products for patients.

Responsibilities (include but are not limited to):

* Develop and implement regulatory product strategies
* Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, contingencies, and directives.
* Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
* Lead and oversee activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
* Plan, prepare, and review submissions to required authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects
* Represent the regulatory function on cross-functional development teams
* Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing programs
* Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
* Serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams in global strategies and advise the US Regulatory Lead (USRL) in the development of applicable strategies and execution of filings
* Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and work with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
* Coordinate and prepare responses to requests for information from regulatory authorities
* Train, manage, and mentor other regulatory affairs personnel
* Work externally to engage in regulatory policy initiatives
* Other duties as assigned

Requirements:

* PhD or PharmD in a scientific discipline preferred along with at least 8 years of experience in industry related Regulatory Affairs (or BS/MS with at least 10 years of relevant experience)
* Knowledge and understanding of global regulations and guidelines
* Previous experience in the preparation and submission of regulatory documents
* Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
* Experience with investigational drugs, including late stage development, and marketed products
* Ability to work in a cross-functional team environment with experience managing people and project teams
* Strong attention to detail and the ability to prioritize multiple tasks
* Excellent organizational, computer and documentation skills and an ability to prioritize effectively
* Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment


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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