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Senior Regulatory Affairs Consultant (RoW/Emerging Markets)

Parexel International Corporation

Uxbridge, England, United Kingdom

Job Purpose:

A Senior Consultant

* must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of what services PC provides.

* develops specialist knowledge of a particular subject matter or market.

* provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives.

* serves either as an individual contributor, a workstream lead or provides overall project leadership.

* provides guidance to project team members on technical/process issues.

* ensures the timely performance of work within a project scope to the quality expectations of PC and the client.

* anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.

The expert will provide strategic guidance to our clients and our delivery teams on requirements and submissions, including submissions of new product applications, across international regions.QualificationsInternational Markets Regulatory affairs expert will have a broad understanding of regulatory science and requirements across international regions, and will have several years supporting submissions in these regions, particularly with emerging markets.

An in depth knowledge of international requirements for regulatory affairs is critical for success in this role.

Key Skills and Responsibilities

• Creating and performing regulatory intelligence surveys, providing an objective assessment of intelligence data, communicating regulatory requirements, and proposing submissions strategies to clients.

• Ability to develop International Regulatory Submission Strategies to meet client needs for a wide variety of products/projects.

• Supporting Project leads in working local market Regulatory Affairs experts to optimise strategies for specific submissions

• Guiding delivery teams in the creation of International dossiers

• Identifying and mitigating risk with respect to international submissions

• Ensuring effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.

• Coaching, mentoring and leading regulatory teams to ensure objectives are successfully delivered to time and quality.

• Monitors and keeps abreast of key changes in the regulatory environment of International markets; support and advise accordingly.

• Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.

• Demonstrations of and management experience.

Skills:

* High-level consulting skills

* Critical thinking and problem-solving skills

* Project leadership and management knowledge

* Excellent interpersonal and intercultural communication skills, both written and verbal

* Client-focused approach to work

* Results orientation

* Teamwork and collaboration skills

* Proficiency in local language and extensive working knowledge of the English language

* Networking

* Business analysis

* Self-confidence and control

Knowledge and Experience:

* Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

Education:

* Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

Job posted: 2021-09-16

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