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Job Details

International Regulatory Strategist

Company: Roche
Location: Welwyn
Reference: 201806-109585
Closing Date: 19 Sep 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

The International Regulatory Strategist (International Product Partner) is responsible for leading the development and implementation of the International regulatory strategy for assigned products in Asia Pacific, Eastern Europe Middle East & Africa and Latin America. ...

Requirements:

The International Regulatory Strategist (International Product Partner) is responsible for leading the development and implementation of the International regulatory strategy for assigned products in Asia Pacific, Eastern Europe Middle East & Africa and Latin America. The International Regulatory Strategist is the relevant representative to global teams and affiliates for assigned products, ensuring the requirements of International countries are considered in development and registration plans.

This job is within the Emerging and Regional Affiliates Support Team, who are currently based in Basel and seeking to expand to additional Roche Headquarter sites.

Key activities/responsibilities include:

  • Partner to key stakeholders including the Global Regulatory Leader and affiliates, providing advice and guidance on regulatory requirements, procedures and issues
  • Ensuring clinical development requirements in International countries are integrated into the global development plan
  • Coordinating core dossier dispatch for clinical trial applications (CTAs)
  • Preparation and maintenance of the International Filing Plan for New License Applications, New Indications and Line Extensions
  • Supporting Health Authority Meetings and responding to Health Authority Questions, providing authoring support as needed
  • An ambassador for International regulatory, bringing the voice of the affiliates to the global teams.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Core competencies and skills:

  • Teamwork: work effectively to share responsibility as a team member
  • Strategic and Innovative Thinking: apply regulatory and scientific knowledge to determine solutions and solve complex problems. Develop clear, effective and creative regulatory strategies to support goals
  • Communication and Negotiation Skills: influence individuals or groups on more than one level who may have different interests or goals to reach consensus and achieve team objectives
  • Technical Competence: possess working knowledge of drug development and regulatory environment in pertinent therapeutic area or product class. Understand current and historical regulatory environment and its impact on assigned products

Education and experience:

  • University Degree, preferably in a scientific discipline
  • Minimum 5 years of experience in International Drug Regulatory Affairs
  • Knowledge and experience of global regulatory processes
  • Basic working knowledge of core processes in drug development, manufacturing and marketing
  • Fluency in written and spoken English.

Who we are

  • Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.
  • Roche is an equal opportunity employer.

The closing date for applications is Friday 31st August.

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

Apply for this job: International Regulatory Strategist

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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