3 days ago

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 Responsibilities As
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

- Bachelors 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

: CH-BL-Allschwil

Job

: Clinical Development

Schedule

: Full-time

Job Type

: Standard

Job Posting

: Oct 13, 2017