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Novartis AG

We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life.We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest ideas and work in our company. Read More

Address      International AG CH-4002 Basel Switzerland.
Website      www.novartis.com/
Holding      No Holding Details

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Hd of Registration PV & Med Af

Responsible for managing CPO regulatory approval and outreach programs. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority CPO products and programs.

Major Accountabilities:
- Direct the preparation and presentation of all necessary regulatory documentation for the CPO, through active outreach to CPO and regional medical and CRA personnel, and management of the DRA team
- Develop regulatory-outreach plans working closely with other CRA and Market Access personnel to ensure efficient approval of in-country products and programs
- Allocate DRA personnel and resources to provide necessary documentation and support for high-priority compounds and products
- Provide necessary clinical information and documentation to CPO, regional and corporate personnel, as necessary
- Ensure clear communication channels between CPO Regulatory Affairs personnel and global and regional Development, CRA, and Market Access officers
- Key interfaces include: Head of CRA; BF Heads; SciOps group
Minimum requirements    Bachelor’s degree is required. Scientific/health care field preferred, but not essential. English Extensive experience within a senior RA role, within a Generic or Pharma business. Great understanding of the EU registration process with proven track rec-ord of working with MHRA Good understanding of generic market structures. Strategic partner for commercial operations. Advanced leadership skills; sets clear vision and directions and aligns teams. Motivates and develops to reach out for excellent performance. Inspires to pro-activity and innovation. Advanced DRA know how, acts visionary and future oriented in continu- ously optimising to deliver what is needed to achieve the overall business results. Competent or skilled user of Microsoft Word and Excel, ideally experi- enced with SAP. Good command of local and English language Looks for synergies, facilitates cross DRA interactions. Familiar with working in a complex matrix environment dealing with con- tinuous change and occasionally conflicting priorities. Solid knowhow of project management techniques. Knowhow on quality assurance and pharmaceutical technology. Communication and negotiation skills

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided


+41 61 324 80 01

Contact Name:

not provided

Job Duration:

not provided


+41 61 324 11 11



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