Assoc. Dir, Regional Regulatory Liaison

Job Description

Lead Regional Product Regulatory Strategy

• Responsible to lead regulatory strategy development and execution of pipeline assets for EEMEA region. Supports country prioritization and effective product regulatory submission and approval in a seamless manner through to launch. develops regional/country regulatory strategies for new products filings and Life Cycle Management (LCM) activities (i.e.: new indications, major variations) aligning priorities with business objectives , local regulatory affairs teams and all relevant regional/global stakeholders/governance committees.
• Is assigned to key pipeline programs, ideally, as of Ph IIa (Proof of Concept, PoC) through to last country launch in region.
• Serves as single Point of Contact (POC) for specific products for country regulatory teams /HQ teams/regional stakeholders, including Business, Market Access, Medical, etc.
• Stays updated on our company's pipeline filings, relevant regional and local regulations and guidelines, collects relevant regulatory information (regulatory intelligence) for the region and keeps relevant stakeholders appropriately informed.
• Lead for Health Authority questions:
• Responsible to lead development of the HA responses in
• collaboration with the response team, for new products filings and Life Cycle Management (LCM) activities
• (i.e.: new indications, major variations).
• Coordination of Planning and Execution of Filings:
• Works with all stakeholders to ensure seamless planning and execution, according to the prioritization, resulting in high quality and compliant on-target regulatory submissions, managing the Health Authority questions, on time approvals, and successful launches. Provides support for New Indications and/or Major Variations that impact launch

Project/Process Support

• Leads/Contributes and represent the Region for regional/global projects. Identifies any internal process and/or communication gaps, resolves these or escalates these to regional and global stakeholders for resolution

Qualifications

• Must hold a BS degree and/or Master s, Ph.D., degree in pharmacy or other life science.
• At least 5 years experience in Regulatory field or equivalent.
• The candidate should have knowledge/experience in Regulatory Affairs and regulations, registration guidelines and regulatory processes for new product submissions and life cycle management in general and preferably in the intended region.
• Adapt AI/Digitalization mindset into daily practice
• Ability to understand/navigate through scientific content
• Excellent communication skills (both verbal and oral) in English.

Experience

Required Skills

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