Global Drug Regulatory Affairs Project Leader

Actelion Pharmaceuticals Ltd

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Global Drug Regulatory Affairs Project Leader

Global Drug Regulatory Affairs Project Leader-(17000079)Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Global DRA Project Leader.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 ResponsibilitiesAs part of his/her Global DRA Project Leader duties on assigned projects, the following responsibilities apply:

* Define and provide optimal global regulatory strategies to support the development and approval of new drugs as well as product life-cycle management activities for assigned product(s)
* Lead creation of regulatory function plans, including identification and critical assessment of regulatory issues
* Provide consolidated interpretation of relevant Health Authority regulatory guidelines for the development and approval of new drugs as well as product life-cycle management
* Lead the global submission planning process, creation, review and finalization of key regulatory documents intended for submission to HAs
* Represent DRA in lifecycle-, CT- other project related meetings, management committees and governance related meetings
* Lead creation, review, finalization and maintenance of CCDS for assigned products including communication of changes (with supporting documentation) to affiliates for implementation
* Establish and lead Regulatory sub-teams at relevant points in development with communication of plans and updates on a regular basis
* Ensure communication and regulatory support for other countries (ex US) in collaboration with the International DRA project manager, affiliate and regulatory operations, as needed
* Collaborate closely with the US based DRA partner for regulatory considerations, strategy and key regulatory document
* Ensure that DRA project milestones are achieved
* Review critically all global promotional material prior to country specific review
* As part of his/her responsibilities as EU DRA Project Leader the resource will:
* Provide EU regulatory strategic input, liaise with EMA as primary regulatory contact and with other EU NCA, ensure EU labeling (Annexes and associated documents) remains in compliance with CCDS and EU/ICH regulations, be responsible for and contribute to ensuring creation, critical review, finalization of EU specific regulatory documents i.e. IMPD, CHMP Scientific Advice- and other meeting briefing books, annual reports, Orphan drug applications, PIP, Module 1 documents for EU MAA etc.

Candidate Requirements

* Bachelor's Degree in life sciences, secondary degree (PhD) preferred
* At least 5 years of regulatory experience
* Good knowledge of regulatory legislation and guidelines (ICH and EU) and major global regulatory systems
* In depth knowledge and experience with EMA and NCA in EU. Experience with various types of EU submissions
* Good understanding of the regulatory aspects at various stages of development, from entry-into-man
* to post approval activities
* Experience working and communicating with the EMA/NCA, including coordinating and managing meetings for scientific advice
* Familiarity with clinical trial methodology and statistics
* Excellent communication, interpersonal, negotiation and problem solving skills
* Organizational awareness (e.g. understands interrelationships between functions, departments and business priorities)
* Effective team player, with experience working in cross-functional and global teams, but also able to work independently
* Ability to work within tight timelines with excellent project management 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



:Clinical Development



Job Type


Job Posting

:Aug 30, 2017