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AX-7255 CMC Regulatory Affairs Director

AXESS Ltd Published: 6th June 2019
Location
Berkshire, United Kingdom
Job Type

Description

Ref: AX-7252

 

JOB SUMMARY

Are you an experienced CMC Regulatory Affairs professional looking to achieve a Director level positon? AXESS have partnered with a leading global biopharma to seek a Director to manage CMOs and strategic activities.

 

BACKGROUND

Global specialty-driven biotechnology group

Offer products in oncology and endocrinology amongst others

Strong pipeline

Launches anticipated over the next 2 years

 

PRIMARY DUTIES

The Director, CMC Regulatory Affairs will determine the required global regulatory CMC strategy to support the department and lead regulatory CMC team to deliver.

Overall responsibility and leadership for the strategy and execution of CMC regulatory filings including authoring, coordination, review and approval for the assigned product portfolio, working closely with vendors and partner companies to ensure alignment.

Ensure that an effective CMC Regulatory function is developed so that the quality of the Company’s products are enhanced or maintained, the patients’ interests are protected and company’s objectives are met.

Managing activities for the portfolio and what is required in relation to external manufacturing, ensuring thorough communication through the CMC regulatory process, developing related procedures to ensure compliance.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

Bachelor's degree in Science

Substantial experience in the preparation and submission of CMC filings (module 3 and 2.3) in a US and European environment

Experience with other global markets such as Australia, Canada, Switzerland and Emerging markets advantageous.

Proven significant experience in the regulatory CMC biologics, small molecules and High Potency field.

Particularly, sound technical knowledge of the manufacture of pharmaceuticals and sterile biological/HiPo drug substances and drug products and appropriate understanding of all CMC disciplines.

Experience with orphan drug designation, paediatric licences and Radiation Therapies is desirable.

Sound experience in managing biological product site transfers and associated comparability plans.

Strong regulatory writing experience and familiarity with eCTD formats and publishing support functions.

Experience leading scientific advice meetings

Line Management of remote teams up to Manager Level experience

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

 

BENEFITS:

Comprehensive

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7255.

To apply, please click the APPLY ONLINE button.

 

KEYWORDS:

Associate Director, Associate director regulatory affairs, Director regulatory affairs, Director reg affairs, regulatory director, Director regulatory affairs CMC, CMC regulatory affairs, CMC,  Regulatory, reg, Regulatory Affairs, , MAA, marketed products, Regulatory quality, module 3, regulatory strategy, submissions, marketed products, manufacturing, regulatory, reg affairs,  post marketing regulatory, lifecycle management, development, MAA, market authorisation, market authorization, centralized, immunology, allergies, allergy.

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market.

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