Assoc. Dir, Regional Regulatory Liaison, EEMEA

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*** Please note there is no relocation for this position. The candidate will continue to work from her/his current location.

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 in global working environment

Required Skills:

Preferred Skills:

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