Global Program Regulatory Director (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 259714BR


Stellenbeschreibung

Regulatory Strategy:

• Provide regulatory leadership to assigned program(s)
• Develop high quality and globally aligned regulatory strategies to achieve
optimal development objectives and life cycle management plans
• Evaluate and clearly communicate to management regulatory risks/gaps and
trade-offs for the overall development plan and develop
mitigation/contingency plans for identified risks
• Responsible for development and implementation of the Regulatory
Functional Plan
• Lead interactions with regulatory consultants/advisors for strategic input and
challenge
• Represent RASB on the GPTs and communicate key program information to
regulatory subteam members and RASB management
• Provide strategic input to GPT and sub-team on key HA documents,
obtaining appropriate line endorsement as appropriate
• Provide strategic regulatory input into BD&L Due Diligence evaluations as
required

HA Interactions:

• Develop global regulatory strategy and plans for Health Authority (HA)
interactions as appropriate
• Contribute to and review HA responses, as required, to ensure appropriate,
consistent and complete answers to any HA questions
• May lead interaction with HAs during key HA Meetings

Submissions and Approvals:

• Lead the global submission planning process, including potential Advisory
Committees
• Lead regulatory submission process throughout program lifecycle on behalf
of GPT. This includes oversight of submission plan, generation and sign-off of
key regulatory/response components

Prescribing Information:

• Provide input to RASB labeling for developing the Prescribing Information
based on PI of local reference product
• Responsible for communicating to RASB labeling any product-specific
updates affecting the PI

Managerial:

• Effective matrix management of regulatory team(s) consisting of Regulatory
Managers and Associates and other RASB line functions, providing, to the
extent possible, mentorship and opportunities for growth and development



Research & Development


Mindestanforderungen

Requirements:

• Science based BS or MS with requisite experience and demonstrated
capability. Advanced degree (MD, PhD, PharmD) preferred
• Minimum 6-8 years of regulatory and drug/biologic development experience,
ideally spanning activities in Phases I-IV
• Minimum 2-5 years of demonstrated leadership and accomplishment in all
aspects of regulatory affairs in a global/matrix environment in the
pharmaceutical industry
• Major involvement in a CTD/MAA/BLA submission and approval
• Leadership role in HA negotiations in multiple regions
• Proven success in global biologic regulatory submissions
• Excellent management, interpersonal, communication, negotiation and
problem solving skills
• Fluency in English as a business language. Additional language is an asset



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