Director Regulatory Affairs CMC - Biologics

Lawrence Harvey

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Job ID :

11522


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--Pennsylvania,Pennsylvania,


Key Skills :

Regulatory Affairs BLA Biologics Bisimilars


Salary :

Negotiable


Date Posted :

18 May, 2018



Company Name :

Lawrence Harvey


Location1 :

Pennsylvania




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Director Regulatory Affairs CMC - Biologics

East Coast

Working together with one of our international clients, SciPro Global is actively searching for a Director Regulatory Affairs CMC Biologics to join a strong and established organization where you can provide your regulatory CMC expertise into in-licensing activities or new product development.

My client, a pharmaceutical company based on the East Coast, is looking for someone who wants to join a strong international team to make a difference and change lives. As the Director Regulatory Affairs CMC- Biologics you will be responsible for developing the global Regulatory CMC strategies for the Biologics products to facilitate overall program goals.

Role/ Responsibilities:

* Provide Regulatory CMC expertise on cross-functional project teams, working with external partners, suppliers and contract manufacturers as required, to ensure regulatory CMC requirements are built into project plans and CMC components of regulatory submissions are positioned for successful approval and product launch.
* Lead the preparation of high-quality CMC components of regulatory submissions including clinical trial and variations/supplements as well as registration submissions for major markets ensuring alignment with regulations, guidelines and the clients' policies and procedures and to agreed timelines.
* Lead on CMC elements of regulatory interactions, including preparation of briefing documents, representing regulatory CMC in technical and strategic discussions with Regulatory Agencies' Worldwide and providing Regulatory CMC support for Health Authority Inspections.
* Manage Regulatory CMC aspects of post-approval change controls, liaising with relevant client personnel as well as manufacturing partners to ensure regulatory compliance.
* Assess and manage regulatory CMC risks and issues and champion resolution, gaining key stakeholder alignment.
* Influence the external environment through representation on relevant organizations, attendance, and presentation at conferences.
* As a senior member of the team, will coach and mentor other regulatory professionals, may supervise.

Experience/ Qualifications:

* Minimum of a Bachelor's degree (or equivalent) in a science related field
* 7 years of experience in pharmaceutical industry, regulatory or quality. However, a combination of experience and/or education will be taken into consideration.
* Must possess knowledge and experience of developing RCMC strategies for Biological products, applying knowledge of regulatory requirements for major markets.
* Must possess excellent communication skills, both oral and written

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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