Regulatory Affairs Director

Key People

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Job ID :

11844


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

regulatory affairs, director, manager, senior manager, strategy, cmc


Salary :

£70000 - £90000.00 per annum


Date Posted :

13 Jun, 2018



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for a Regulatory Director to join a leading biopharmaceutical company focused within oncology. Within this role you will be responsible for managing and leading International registrations and provide regulatory support in defining the regulatory strategy for assigned products.

If you are looking to be a part of a company with an unwavering commitment to improving patients' lives and being and part of an exciting, growing team, please enquire for further details.

Responsibilities:

*Overall cross functional planning and execution lead.
*Works closely with Commercial to assess and define a Global expansion plan per product.
*Member of Global expansion steering committee.
*Provide international regulatory strategy support for assigned products (maintaining and extending product registrations in International markets).
*Collaborate closely with all other key GRA stakeholders (including but not limited to Global Regulatory Lead, labelling, CMC, regulatory operations, EU regulatory team to ensure that all aspects of the regional strategy is coordinated and considered.
*Provides regional regulatory expertise to GRL and within GRT by collaborating with our partners in International markets.
*Ensure international strategy is appropriately represented within the GRT and at other appropriate forums (Global Development Team etc.) through the GRL.
*Provides support to GXP inspection activities as required.

Required Knowledge, Skills, and Abilities:

*Knowledge of International regulatory requirements.
*Understanding of the drug development process and laws and regulations affecting pharmaceutical development in International region.
*Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
*Working in a matrix structure and with cross functional teams, requiring negotiation and partnership skills.
*Good understanding of drug/biologics development within pharmaceutical and biotechnology industry or Government Health Agency.
*Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
*Demonstrated ability to coordinate global activities.
Required/Preferred Education:
*Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred

For further details about this role, or for a confidential conversation about other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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