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Associate Director Emerging Market Regulatory
3 months ago
Associate Director, Emerging Market Regulatory Liaison:
Janssen Global Regulatory Affairs organisation is recruiting for an
Associate Director, Emerging Markets (EMEA region) Regulatory Liaison (EMRL) to be based in UK, Netherlands, Belgium, Italy, Poland or Egypt (other Emerging Market locations will also be considered).
Position summary:
The EMRL position resides in the EMEA region and is responsible for working proactively with the local regulatory affairs departments, Global Regulatory Team and head office-based team members (e.g. Strategic Implementation Leader) to define and implement the regional strategy for Emerging Markets for assigned products. It is a sole contributor role with no direct reports, reporting to the EM Regulatory Head. Travel requirements 15-20%.
Country scope:
- Russia/CIS, TURGAN, GCC, JENA, NEMA, ZA-SAA.
The position is accountable for leading and providing region or country input into the global regulatory strategy to global regulatory teams, and identifying regional requirements for successful regulatory filings for new products/indications, including the opportunity for placement of clinical trials within the region where / if appropriate.
This position will be an ad-hoc attendee of the IBVT (Integrated Brand Value team) and will liaise with the EMEA EM Regulatory Snr Director, and inter alia, with the Local Operating Countries (LOCs) and GRTs to develop and facilitate an efficient regulatory strategy to achieve prompt submissions and earliest approvals for Janssen innovative products.
The position also ensures regional affiliates are supplied with timely responses to Health Authority enquiries; as well as regulatory support to all affiliates in the region for the pharmaceutical sector business.
The EMRL will ensure adequate preparation for health authority meetings, and may attend and provide presentations to health authorities, if appropriate.
The EMRL develops the regulatory strategy for the Emerging Markets, aligning this within the EMEA strategy with the EMEA RL.
EMEA RL maintains overall accountability for the entire EMEA region, the EMRL is responsible for developing and delivering the strategy for the EM.
Qualifications:
Education and Experience:
- University degree medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
- Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
- Experience in working in project teams and/or a matrix organization
- Experience in shaping regulatory environment via policy &/or trade associations an advantage
Skills:
- Negotiating and conflict handling skills
- People management skills
- Complex project management skills
- Oral & written communication skills
- Organization & multitasking skills
Knowledge:
- Excellent knowledge of English
- In depth knowledge of the regulatory environment, guidelines and practice of Emerging Markets
Who we are?:
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce.
Through powerful programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
