OverviewCompany DescriptionMundipharma is a global (ex-US) network of independent associated companies that research, develop and manufacture innovative pharmaceutical medicines and consumer healthcare products. We are an agile and fast-paced company seeking to increase access to health care through programmes and effective partnerships.We are forward-looking and dedicated to bringing innovative treatments to many of the world’s most challenging conditions and diseases including: Pain Management & Supportive Care, Consumer Health, Anti-Infectives, Biosimilars, CNS, Diabetes, Oncology, Ophthalmology, Respiratory and transplantation immunity.We make a difference to patient lives by delivering value to healthcare professionals in 120+ countries across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.Job description
Responsibilities

Ambassador for RA in their cluster. Will represent RA actively and positively at cluster leadership levels.
Responsible for the regulatory delivery from in-country personnel or the vendor delivering in-country RA support in the cluster and for the coordination and communication between local markets and central organization for countries in their cluster.
RA commercial partner and country escalation point for their cluster.
Drives optimal regulatory outcomes for the different local markets and ensures governance on regulatory activities.
Active member of the RA leadership team representing their cluster.
People management / Vendor oversight
Lead local markets in the cluster, acting as an escalation point, providing strategic direction and support for all items that may arise.
Responsible for ensuring all country resources deliver quality submissions, data and metrics and observe all processes appropriately.
Manages resources effectively - performance and delivery - whether the team is vendor or internal personnel.
Lead in company interactions with various regulatory functions at central and local level, external partners, health authorities, technical functions outside regulatory affairs, commercial assets and teams across diverse issues in diplomatic and persuasive ways.
Act as ambassador for RA in the clusters, actively demonstrating the value of RA with stakeholders including Commercial, Quality, Supply Chain and ensuring RA supports the business priorities.
Proactively engage effectively with cluster leadership to support local market / cluster RA concerns and issues.
Act as liaison and conduit to coordinate communications between the local RA markets and the central organizations where necessary, e.g. lead communications of regulatory changes to the markets and interact with the local teams to provide advice, oversight and planning RA Portfolio support.
Have a thorough understanding of the local RA landscape (requirements, products, issues, risks, partners, etc.), support local RA teams and raise issues, risks appropriately with RALT members.

Qualifications

Strong regulatory experience and experience in matrix team management in country regulatory.
Experience of effectively working in a matrix environment.
Strong leadership skills, able to interact and integrate different teams, provide solutions and partnership, and have a good level of understanding of different cultural aspects in cooperation of teams.
Knowledge, experience and track record of delivering successful regulatory outcomes for regulatory activities across the cluster, working with diverse Regulatory Authorities.
A strong strategic regulatory mind-set and demonstrated ability in taking the lead in company interactions with various regulatory functions at central and local level, with external partners, health authorities, technical functions outside regulatory affairs, commercial assets and teams across diverse issues in diplomatic and persuasive ways.
Proven cross-cultural communication skills and ability to promote good relations between the central organization and local markets, establishing good cultural communication and willingness to understand country-specific cultural conditions; actively promote good contacts and interaction and to promote friendly relations. Demonstrates diplomatic skills and cultural understanding or the ability to learn in this regard.

What we offer
Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great place to work.
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