Senior Regulatory Manager, Oncology

Key People

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Job ID :

8795


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

regulatory, post approval, registrations, international, global, oncology, haematology, strategy


Salary :

£50000 - £70000 per annum + bonus and benefits


Date Posted :

21 Sep, 2017



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 Senior Regulatory Manager, International Strategy, to join a growing Biopharma client based in Oxfordshire on a permanent basis. Within this role you will be responsible for ensuring the quality of regulatory input and implementation for product development and life cycle management.

You will also contribute to the global expansion of the company's marketed products and oversee select International regulatory projects, ensuring timely registration of products in compliance with applicable regulations and guidance. You will also be responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products.


Essential Functions
*Creates, evaluates, and completes International regulatory projects consistent with the company goals. The successful candidate is responsible for assembling regulatory submissions and international dossiers to non-EU territories
*Develop and implement regulatory strategies to facilitate the progress of global expansion of the company's marketed products
*Serve as the Regulatory Affairs representative on internal and external project teams; assuring the progression of projects by providing strategy
*Work with project-specific subject matter experts to successfully interact with international partners and global health authorities, including meeting preparation and communication of commitments and meeting outcomes
*Manage meetings with marketing partners, and vendors for products/projects
*Maintain awareness of and communicate within the organization changing requirements across the international regulatory landscape (especially with respect to non-EU, emerging markets), updates for regulatory intelligence, and provide regulatory training
*Represent the company in external forums
*May manage and/or mentor junior regulatory professionals

Required Knowledge, Skills, and Abilities
*Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
*Previous experience with global regulatory filings (i.e. Canada, EU, Middle East, Asia-Pacific and South/Central America)
*Proven track record of effective collaboration with third parties/partners and regulatory agencies to obtain market clearance in other countries
*Demonstrated success in management of regulatory activities
oExperience with regulatory agencies and preparation of documentation to support interactions
oAbility to lead health authority interactions
oKnowledge and experience in preparation of global regulatory strategies
oExperience with maintenance of regulatory authorizations and variations in at least two regions
oExperience working on cross-functional development teams (including Commercial and R&D personnel)
*Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
*Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others
*Excellent verbal and written English and communication skills
*Some travel required




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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