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Regional Regulatory Hub Compliance Associate


Boulder, CO 80301
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Job Details

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


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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