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Are you looking for a highly visible regulatory affairs leadership role where you can accelerate regulatory compliance on an international scale? If so, this Regulatory Affairs Management Director role could be an exciting opportunity to explore.

As a Regulatory Affairs Management Director, you will be responsible for supervising the future expansion and implementation of ongoing operations in the several country-specific centers of Global Regulatory Platforms and Delivery in R&D.

This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Create and lead teams at regulatory platform delivery locations on specific regulatory activities and deliverables such as Chemical Manufacturing & Controls (CMC) dossiers authoring, submission dossiers, publishing, data management, archiving, and market specific requirements on multiple projects for Pharmaceuticals and Vaccines.
  • Direct line management responsibility for and leadership of staff responsible for the delivery of regulatory outputs
  • Accountable for the success of the Global Regulatory Platform & Delivery (GRPD) country centers via appropriate resourcing, management oversight, risk mitigation, simplification and alignment activities
  • Identify, develop and maintain third party resourcing business partners to ensure scalability, flexibility and resourcing capacity required for the delivery of GRPD outputs,
  • Maintain quality of output and speed of delivery within defined budgets
  • Collaborate with and influence senior stakeholders at SVP, VP and Director level, in a complex and fast evolving environment, across multiple countries, to assure the strategic success set up and/or expansion of country GRPD centers.
  • Why you?

    Basic Qualifications:

    We are looking for professionals with these required skills to achieve our goals:

  • Bachelors degree
  • Experience in pharmaceutical industry
  • Experience in managing global teams across different locations
  • Experience supporting worldwide regulatory requirements
  • Preferred Qualifications:

    If you have the following characteristics, it would be a plus:

  • Masters degree
  • Extensive knowledge of drug development and manufacturing and supply processes.
  • Ability to effectively influence key stakeholders at all levels of the organization
  • Consulting/advisory experience at senior management level
  • Why GSK?

    Our values and expectationsare at the heart of everything we do and form an important part of our culture.

    These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

    Associated topics: care, facebook, festival, major gift, product market, public, regulatory, solicitation, stewardship, twitter

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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