Requisition ID:
76981

Position:
Full-Time Regular

Open date:
Jul 26, 2012 1:33:45 PM

Functional area:
Regulatory Affairs

Location:
Uxbridge Middlesex, Southeast England

Required degrees:
Not Indicated

Relocation:
Not Indicated

Basic qualifications:

• Graduate/PhD level or equivalent, with experience in the pharmaceutical industry, including UK regulatory experience.
• Comprehensive knowledge of drug development process and regulatory affairs,
• In depth understanding and practical experience of UK and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
• Has an understanding of the impact of the UK health environment and proposed changes which are likely to impact the business in the medium term.
• Comprehensive knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities

Preferred qualifications:
See basic requirements

Details:
Job Purpose
Has individual responsibility for progressing the regulatory status of a defined number of significant / complex products and development compounds.
Responsible for regulatory submissions for these products and is the primary interface with the MHRA.
Leadership of brand and cross-functional meetings when these are driven by regulatory concerns and will proactively contribute to others.
Responsible for assigned non-product activities of significance to the department /company. These may be of a complex nature.
Proactive leadership in creating and defining effective regulatory strategy, influencing as needed to reflect business needs.

Responsibilities

Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.

Ensures that submissions to the MHRA are complete, are of a high standard, and are filed rapidly.

Co-ordinates UK input into responses to regulatory questions, ensuring these are in alignment with agreed strategic direction.

Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions

Builds and maintains effective relationships with internal and external stakeholders including GSK global regulatory groups, the MHRA, GSK commercial and clinical teams.

Co-ordinates meetings with MHRA and plays a key role in these interactions

Is an approval signatory for key promotional materials.

Capabilities:
--Appreciates wider communication network and likely impact of information on others. Able to present clearly and effectively to a variety of audiences internal and external to GSK.
--Builds and maintains rapport, trust and common understanding with key contacts and uses these contacts to improve working relationships, gather information and get things done.
Ability to interact with complete confidence with all levels of relevant personnel and with regulatory agency reviewers.
--Customer focused, follows up on commitments and requests for input. Ability to view business from customers’ perspective and understands impact of decisions/actions on other functional areas.
--Has excellent organisational skills, can work under pressure and makes contingency plans.
--Is able to recommend an effective regulatory approach to an issue and exert influence to obtain agreement from key contacts, some of whom may be more senior in the organisation, to a defined course of action where there are potentially conflicting issues
--Works co-operatively with others in either a leadership role or as a key team member, to achieve business goals and objectives. Valued and respected by team members who actively seek help from the individual. Adopts a “can do” attitude. Spends time on reviewing how team works, to learn from experience, assess what is working/what is not.

Closing date for application: Thursday the 9th of August 2012

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

Contact information:
You may apply for this position online by selecting the Apply now button.

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GlaxoSmithKline - 10 months ago