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Job Details

Executive Director of Regulatory Affairs.

Company: TEC Group International
Location:
Reference: SAMM
Closing Date: 18 Dec 16
Type: Full Time
Salary (£): 100,000+
Benefits:

Job Summary:

The consultant running this executive search is Sam Murphy. For more information or to apply to the position please contact Sam via email – sam.murphy@tecgroup.net

Requirements:

TEC Group is currently partnered with a global pharmaceutical company that has established a strong and reputable name in the production of innovative drugs for the treatment of Obstetrics, Gynaecologists, Urologists and an exciting new area of focus in the coming years will be the treatment of Brain Trauma Injuries. 

The position will demand an expert knowledge of global regulations while a commercial mind set.

A solid background balancing cost and time to market is going to be key when screening new candidates. This is a brand new position for the company and they are hopeful to find a talented candidate with a natural entrepreneurial flair and a real passion for pushing the boundaries of what has been done before. One of the first points of call will be to build a team in the UK so line management and recruitment experience is accentual. The position will have up to 6 direct reports located all over the world as well as working with internal management teams to hit deadlines and achieve common goals. The selected candidate will have a background managing project from birth to market and full global life cycle management experience.  

Responsibilities

Possesses strong knowledge and understanding of pharmaceutical regulations globally.
Coordinate efforts between all stake holders (Pharma Development, Marketing, Supply Chain and Regulatory Affairs) involved in Product Development and Life Cycle Management projects.
Evaluate and propose efficient regulatory pathways (balance between Cost and Time to Market) to ensure the registration of life cycle developments or new product projects.
Understand the business opportunities in order to prioritize projects and resources based on discussion with the Senior Management Team.
Able to manage resources from various functions of the organization and located around the world ensuring that timelines and budget commitments are maintained.
Select, negotiate and manage external service providers involved in the projects.
Key team member, part of the evaluation and presentation of new opportunities to the Senior Management.
Liaise directly with local health authorities to develop and lead the company’s regulatory strategies for product categories in line with global strategic plans.
Coordinate efforts between the development teams and local RA consultants to obtain and prepare data required in the preparation of regulatory and technical documentation of registration files.
Work with a team of regional/local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorization approvals in compliance with individual health authority and local government regulations.

 

 

 

 

 Profile

International regulatory affairs senior manager with around 20 years of international experience in managing Regulatory Affairs.
Extensive regulatory affairs experience, focusing on and expertise in life cycle management projects in multiple countries.
Proven track record of successful registrations around the world.
Extensive international Project Management experience.
Well-developed business acumen able to prioritize in complex international arena.
Seasoned professional routinely involved in presentations at senior management and/or board level.
Team player experienced in working in a cross functional environment to achieve common goals and objectives.
Adept at solving problems and understanding business priorities when compromise is required.

 Compensation Package

The company offer a competitive salary and package that is higher than market average. Some of the position benefits include a company car, pension, premium health care and a shares scheme from day one. A full progression ladder is offered to show the natural progression within the role while allowing a creative platform for the selected candidate to choose areas of expertise. While the company continues to grow they would like to offer more flexibility to the position that could lead to a flexible work life balance. 

Apply for this job: Executive Director of Regulatory Affairs.

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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