2 days ago

Drug Regulatory Affairs Project Manager

Actelion Pharmaceuticals Ltd

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Drug Regulatory Affairs Project Manager

Drug Regulatory Affairs Project Manager - (170000D6) Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of
Johnson & Johnson, is recruiting for Drug Regulatory Affairs Project Manager. As part of the Janssen Pharmaceutical
Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and
better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the
most promising science. We collaborate with the world for the health of everyone in it. Actelion is a leader in the
field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from
WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Job Responsibilities

- Acquire and maintain an overview of relevant regulatory requirements and
guidelines
- Assume EU regulatory responsibility for individual tasks on assigned projects, such as the creation and finalization
of key regulatory documents (IMPD) as well as ensuring submission to HA (EU) scientific advice packages, PIPs, Orphan
applications, Module 1 documents for EU and support for global submissions (MAA, etc.), variations
- Represent Drug Regulatory Affairs (together with the Global DRA Project Leader) in lifecycle and other project or
governance-related meetings
- Collaborate closely with the Global US-based DRA partner for regulatory
considerations on assigned projects
- Support Global DRA Project Leader on creation and finalization of strategic DRA documents such as Regulatory
Functional Plan

Candidate Requirements

- Bachelors Degree, in life sciences, medicine, pharmacy or equivalent
- Basic knowledge of regulatory legislation and guidelines
- Basic understanding of the regulatory aspects at various stages of development, from EIM to post-approval activities
- Familiarity with clinical trial methodology and statistics
- Capable of working independently as well as effective team player
- Ability to work within tight timelines with very good project management skills
- Excellent communication, interpersonal, negotiation and problem solving skills
- Accuracy, reliability and diligence
- Excellent spoken and written English

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your
application.

Primary Location

: CH-BL-Allschwil

Job

: Regulatory Affairs

Schedule

: Full-time

Job Type

: Standard

Job Posting

: Dec 4, 2017