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Head of Global Regulatory Affairs (m/f/d) RX Pharmaceuticals #26573
Zum Unternehmen

Optares GmbH & Co. KG
Our client is a NASDAQ listed biotechnology company with the global
Headquarter in Germany. The companies focus is the research and development
of new medicines for the treatment of inflammatory diseases within a global
development approach. Our client stands out for an excellent team of highly
motivated and skilled individuals who put strong emphasis on a team effort

Zur Position
Head of Global Regulatory Affairs (m/f/d) RX Pharmaceuticals #26573
 [Referenznr. 26573]
Lead the development and execution of all clinical, non-clinical, and commercial
regulatory strategies for the new product and new assets to maximize global
regulatory success

Provide regulatory guidance and strategy and assessing regulatory risk for the

Understand standard and alternative approaches to registration for antibodies
and small molecules in the area of Infectious Diseases/COVID, Immuno-
Dermatology, Dermato-Oncology and Autoimmune Diseases.

Ensure project team colleagues, line management, and key stakeholders are
apprised of developments that may impact regulatory success, exercising sound
judgement and communicating in a professional and timely manner

Lead interactions with EMA and FDA, including planning, executing, and leading
the coordination and preparation of teams for health authority meetings.

Develop regulatory project plans and timelines, manage execution and ensure all
projects are appropriately prioritized and key goals are met on time.

Establish an internal Regulatory Affairs Team and provide leadership and
development for direct reports

Provide leadership and direction to staff, consultants, and vendors supporting
regulatory affairs.

Leading Regulatory Affairs Operations, i.e., leading the development of
regulatory operations including the prioritization of internal or external
resources to best support the several clinical programs from early phases to
filing and registration.

Oversee compilation, electronic processing, and publishing of US and global
submissions (INDs, CTAs, NDAs, etc.) in time and compliant with regulatory
authority requirements, including authorship of critical documents as needed

Oversee the creation and maintenance of relevant SOPs, Work Instructions, and
other necessary guidance.

Budget responsibility for the assigned department

Participate in strategic and regulatory evaluations of in-licensing matters
MD or PhD or similar advanced degree in relevant scientific field (e.g.
pharmacology, immunology, molecular biology).

Minimum of 10-15 years’ professional experience in the
biotechnology/pharmaceutical environment in the development of NBE’s and

Strong knowledge of the Regulatory environment in US and EU at minimum.

Ten or more years of experience in global Regulatory Affairs for pharmaceutical
drugs and/or biologics. Senior-level experience interacting with competent
authorities, in particular, the FDA and EMA.

Successful track record of filing Marketing Applications (NDA, MAA, BLA, etc)
along with briefing packages, orphan drug applications, and various other
regulatory documents.

Extensive leadership, management and project management experience in the
multiple facets of drug regulatory affairs and drug development.

Ability to both think strategically and, in the meantime, be hands-on, pay
attention to details and be involved in the everyday aspects for all regulatory

Ability to drive decision-making within a cross-functional, cross-divisional and
cross-cultural, global team structure and requires global mindset and cultural
awareness in working with senior leadership in other regions and in managing
cross-regional projects

Proven ability to manage complex projects, with the flexibility and adaptability
to re-prioritize workload to meet changing timelines.

Strong written and verbal Communication Skills: ability to express oneself
clearly and concisely to external partners, vendors or with others within the
team; ability to message key issues appropriately and document issues and/or
concerns concisely and comprehensively; ability to adjust language and/or
terminology appropriate for the audience; demonstrated ability to clearly and
concisely communicate / present key information to senior management

Strong team-player with collaborative, respectful and flexible attitude and high

Highly self-motivated and able to drive activities, solution-oriented personality

Entrepreneurial spirit, agile and flexible in a rapidly changing environment.

Experience with Immuno-Dermatology or Autoimmune programs.

Must be comfortable working for a small organization, and able to handle
Wir bieten
Seit 2003 vermittelt Optares Medical erfolgreich Fach- und Führungskräfte an Unternehmen der pharmazeutischen, biotechnologischen und medizintechnischen Industrie. Dabei profitieren Sie als Kandidat (m/w/d) durch unsere langjährige Branchenexpertise und unser weit reichendes Netzwerk zu den jeweiligen Entscheidungsträgern. Wir ermöglichen Ihnen somit den Zugang zu passgenauen Positionen inklusive echten Herausforderungen und entsprechenden Weiterentwicklungsmöglichkeiten.

Die professionelle, diskrete und transparente Betreuung unserer Kandidaten (m/w/d) während des gesamten Bewerbungsprozesses steht dabei für uns im Mittelpunkt.

Ihr Ansprechpartner
Gewünschte Qualifikationen

Verkauf/Vertrieb --Projektierung
Einsatzort (Freitext)
Einsatzort (Region)
(Deutschland) Bayern
Kontakt für Bewerber

Herr Bastian Hennlich
Senior Personalberater
Tel. +49 441 21879-45



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