Vice President, Regulatory Affairs NA

Lawrence Harvey

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Job ID :

10319


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--Pennsylvania,Pittsburgh,


Key Skills :

Generic OTC Over the counter Brand Regulatory FDA


Salary :

Negotiable


Date Posted :

05 Feb, 2018



Company Name :

Lawrence Harvey


Location1 :

Pittsburgh




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Vice President, Regulatory Affairs - NA

East Coast

Working together with one of our international clients, SciPro Global are actively searching for a Vice President, Regulatory Affairs, NA to join a strong and established organization to lead a great team of regulatory affairs professionals.

My client, a pharmaceutical company based on the East Coast, is looking for someone who wants to join a strong internationally team to make a difference and change lives. As the Vice President, Regulatory Affairs, NA you will be responsible for the development and implementation of the regulatory strategy for the United States and Canada across the business generics, brand and OTC products. As well as the strategy, you will also be responsible for the oversight of the day-to-day operations and of the planning, preparation, review and evaluation of documents for submission to the FDA.

Role/ Responsibilities:

* Provide daily oversight, counsel and guidance to Regulatory Affairs staff members and to other functional areas and manages regulatory activities for new and approved products to meet both FDA requirements and company objectives.
* Oversees the processes governing preparation of major regulatory filings, including INDs, BLAs, NDAs, and ANDAs
* Provide advice, regulatory guidance and status reports to senior management, as appropriate.
* Maintain positive relationships with FDA as primary liaison on submissions, communications and specific projects.
* Provide strategic regulatory guidance for new and approved products, as needed. Provide input to minimize regulatory issues and help prevent unnecessary regulatory delays.
* Oversee Distribution Regulatory Compliance activities and coordination across client facilities, including State Licensing, DSCSA, and DEA compliance.
* Provide daily direction to Regulatory Affairs staff including Regulatory professional leaders, administrative, documentation support, labeling, and regulatory submission management functions. Manage employee development activities.
* Responsible for maintaining operational/expense budget, headcount budget, and capital budget for the North America Regulatory Affairs department. Review monthly budget performance.
* Maintain awareness of all regulatory activities and current statuses regarding new and approved drug products. Stay current with state-of-the-art-standards on the regulatory process.
* Interact with other functional areas and executive leadership as needed to provide guidance with respect to regulatory issues.
* Ensure process and resources are in place to allow timely review of internal documentation such as change control information, method transfer packages, batch records documentation, validation protocols, and reports.

Experience/ Qualifications:

* Bachelor's degree (or equivalent), and a minimum of 15 years of experience in Regulatory Affairs is required. Related experience may also be considered.
* 10 years of experience in a Regulatory Affairs leadership role where direct relationships with regulatory authorities were built and/or maintained is required.
* Must possess expert-level knowledge and interpretation of FDA regulations and industry guidances, policies, and procedures pertaining to the submission, approval and post-approval processes.
* Ability to read and interpret comprehensive and intricate research documents. Ability to clearly and succinctly write scientific/regulatory summaries and technical correspondence.
* Previous management experience is required.

If this is something you would be interested in or know someone who might be, please apply to the role directly or alternatively, you can reach out to me at 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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