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Regional Regulatory Hub Compliance Associate

Pfizer


Location:
Boulder, CO 80301
Date:
02/13/2018
2018-02-132018-03-16
Pfizer
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Job Details

Regional Regulatory Hub Compliance Associate (Temporary Contract - Max 1 year)







**Department/Group**



Safety and Regulatory Quality [SRQ]-Quality Management







**Organizational Relationship(s) including to whom the position reports :**







+ Reports to Morocco Regulatory Manager and Regional Regulatory Hub Team Lead







+ Close collaboration with EMEA/CANZ PEARL SMEs, Cluster SPOCs , project manager, CLT rep for EU markets, Regional Regulatory Hub strategist (RRHS) team for non-EU markets



+ Partner with other Stakeholders: RIM , GCMC







**Position Purpose**







+ Support WSR Innovative, Europe and International portfolio data management in different regulatory systems such as PEARL.







**Primary Responsibilities**







+ Project Management can manage complex and multiple projects



+ Ensuring that the company databases and systems contain the required information; ensuring compliance as per established processes and SOPs.



+ Collaborating with WSR-I and any other stakeholders to collect, organize and populate data in the appropriate databases and systems, as per agreed timelines.



+ Generating and compiling reports from numerous sources (e.g. PEARL, PDM and VP) allowing identification of status of submissions and approvals, as per agreed timelines.



+ Communicating on a regular basis to sponsor and direct manager the progress of the project, and any issues identified.



+ Supporting the WSR-I team with all relevant compliance activities, keeping all projects on track as per agreed timelines.



+ Complete departmental training in a timely manner to address corporate and regulatory needs.



+ As applicable, contribute to regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance and innovation.







**Technical Skill Requirements**







+ **Technical and scientific knowledge of pharmaceutical products**







Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment.







+ **Understanding of different regulatory environments**







+ **Project Management**







Can manage complex and multiple projects







+ **Communication skills**







Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.







+ **Problem Solving**







Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.







+ **Detailed Orientated**







Can be thorough and complete with high quality.







+ **Team working**







Comfortable acting in a wide range of team roles in the wider project interest.







+ **Strong quality and compliance orientation**







Has an understanding of regulatory compliance issues and the potential impact of compliance related issues on meeting business objectives







+ **Adaptability**







Able to build effective working relationships and deliver results in wide range of environments and cultures.







**Qualifications (i.e., preferred education, experience, attributes)**







+ Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.



+ Appropriate Regulatory Experience 1-3 years



+ Analytical and project management skills, (Project Management certification is an advantage)



+ Proven ability to manage complex regulatory or drug development issues.



+ Proven ability to consistently deliver to time, cost and quality standards.



+ Fluent in English - written and spoken communication skills



+ Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred



+ History of delivery - country and/or regional



+ Countries/Regional Knowledge EMEA Region (Middle East, Africa,.... )







End Posting = 22 February 2018







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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