Regulatory Affairs Consultant - Emerging Markets
An internationally known biotechnology company has an opening for a Regulatory Affairs Consultant, Emerging Markets, job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.
- Driving and nurturing the development of colleagues locally (UK) and in the region of responsibility where applicable.
- Building and maintaining excellent relationships with regional Emerging Market regulatory agencies, distributors, contractors and corporate partners whilst representing the agreed company positioning.
- Shaping the strategic vision for the region, capability building to meet current and future needs of the business.
- Overseeing direct development and execution of regional development and labelling strategies for all products (e.g., new marketing applications and lifecycle maintenance) within defined IGM region.
Being the Emerging Market Product Lead for defined products and ensure GEM product strategy is factored into Global Product Development Strategy.
- Representing the company and proactively fosters excellent working relationships with International regulatory authorities, trade associations distributors, contractors and corporate partners.
- Developing trust-based relationships with key internal partners; regional commercial, medical, market access, supply chain.
- Exhibiting exemplary leadership, for UK based colleagues, through talent engagement and retention, management and development.
- Providing leadership, direction and management of regional colleagues through two-way communication, cascading of information and goals and encouraging an open continuous improvement environment where "no idea is too stupid".
- Ensuring the development, challenge and validation, communication and execution of regional new product and lifecycle regulatory strategies, in collaboration with regional stakeholders including commercial, market access, medical and global stakeholders through GEM product leads.
- Leading regional regulatory activities to ensure during early stage development key regional issues are considered/highlighted to all RDPL/PDC teams (through Product Leads).
- Critical to develop close business partnership with regional commercial lead, sub regional leads & country managers.
- Seeking to build and enhance relationships with key external stakeholders and Regulatory Agencies in the region.
- Ensuring Regulatory representation and the company's policy aligned input to regional and country industry associations, whilst ensuring alignment with local business colleagues.
- Ensuring process and structure in place to manage oversight of regulatory activities, budgeting, resourcing and regulatory compliance within region.
- Partnering with principal regional and/or global stakeholders to support/oversee due diligence and inspection readiness activities. (Proposed new partners or regional CRO)
- Driving GSRS ethos, team strategy and adaptation according to business need.
- Providing consolidated Global Emerging Markets input and insight to development teams (RDPL/PDC), to ensure GEM has a voice and GEM development considerations are considered as part of the development program.
- Accountable for the development and agreement of regional annual budget and headcount. (working closely with regional and country managers)
- Accountable for development, communication, and implementation of New Product and Lifecycle strategies in their region.
- Working/liaising/partnering directly with the GEM Lead internally, direct liaison expected with Regional commercial heads and country managers.
- Driving strategy and direction of the RA function in the region, co-accountable for GEM leadership and direction.
Skills and Requirements:
- Minimum BA/BS/University degree required, Life/Health Sciences preferred.
- Minimum 7+ years pharmaceutical/biotechnology industry experience in International/Regulatory Emerging Markets.
- Comprehensive knowledge of global and emerging market trends and broad requirements.
Experience in interpretation and communication of global and emerging market regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of emerging market assessment of major regulatory submissions, variations or supplements.
- Significant experience in interfacing with Emerging Market regulatory authorities or policy makers.
- Attention to detail including proven ability to manage multiple, competing priorities
- Experience working with regional / global commercial teams and leads.
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Elise Stewart at 0207 440 0633 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.