Global DRA Submission Management

Actelion Pharmaceuticals Ltd

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Global DRA Submission Management

Global DRA Submission Management - (1800000X) Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of
Johnson & Johnson, is recruiting for Global DRA Submission Management. 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

- Ensure all regulatory submissions supporting the development, registration and marketing of products worldwide are
planned, coordinated, assembled/published and delivered consistent with regulatory requirements, internal quality
standards and business priorities, being responsible for the interface, communication and transparency with relevant
internal functions and groups in this regard

- Be accountable for the leading and managing the DRA submissions operations teams
- Strategically drive the development and implementation of efficient business processes for managing worldwide
regulatory submissions (eCTD, electronic and paper, datasets)
- Drive operational excellence, compliance, integrity and alignment through adherence with internal policies and FDA,
EU and international regulatory requirements for submissions
- Proactively manage the assessment of impact of new regulations and guidance on regulatory submission activities
- Manage the identification of potential risks and performance challenges that may impact the quality, timelines,
and/or resources of submission activities
- Proactively identify quality issues and propose and implement pragmatic actions to address them
- Contribute in developing global and local SOPs, processes and performance metrics to measure compliance and progress
consistently across submission activities

- Provide support to all regulatory business systems, ensuring effective management of regulatory information and
documents and establishing capabilities to ensure the effective planning and tracking of essential regulatory
activities and commitments.

- Proactively manage the assessment, development, update and implementation of DRA-related submissions tools and
- Lead and facilitate collaboration on regulatory e-solutions for submissions with Corporate IT strategy and technical
- Manage the submission-related interface with all relevant regulatory functions as well as other functions within

Candidate Requirements

- Masters degree or equivalent university education/degree in life science or healthcare
- Minimum 5 years of relevant experience in regulatory affairs operations (EU and US), with at least 2 years
experience in a line management role
- Excellent working knowledge of the US and EU regulations and guidelines governing both paper and electronic (eCTD)
submissions, and the ability to interpret and implement them as appropriate
- Familiarity with electronic publication tools and electronic document management systems
- Solid understanding of datasets requirements for US submissions
- Fluency in English (fluency in other languages is advantageous)
- Ability and willingness to travel internationally
- Highly computer literate and excellent MS Office skills (MS Word, Excel, PowerPoint)
- Excellent management and people skills, capable of creating and fostering a team, including the ability to develop a
culture of empowerment, ownership and accountability within the group environment
- Proven ability to coach, develop and mentor people
- Excellent organizational, analytical, problem-solving, and multi-tasking skills
- Ability to work effectively within tight timelines, often under pressure, and to provide leadership and direction to
team members in these circumstances
- Ability to communicate effectively across functions globally
- Ability to work across all levels of an organization in a global matrix environment
- Proactive and forward thinking in initiating and managing change, improvements and innovations

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

Primary Location

: CH-BL-Allschwil


: Regulatory Affairs


: Full-time

Job Type

: Standard

Job Posting

: Jan 18, 2018