Regulatory Associate Director - Emerging Markets
An internationally known biotechnology company has an opening for a Regulatory Associate Director -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.
- Inform and advise company product lead colleagues of China development and submission requirements and to ensure they remain aware/are updated of China activities for their assets.
- To provide aligned "expert" guidance and insights of China development and submission requirements to PDC / RDPL lead groups and senior management and, where required, present to senior management groups (e.g PDC-OC) proposed cross line agreed regulatory/clinical strategies for assets under responsibility.
- To drive development and execution of Agency Engagement and submissions strategy working in collaboration with Regional Lead, China RA team, regional commercial leads, and asset team stakeholders.
- To represent Global regulatory as Regional/China at agency meetings in collaboration with local RA colleague as required.
- To be the Emerging Market Product Lead for defined products and to ensure company product strategy is factored into Global Product Development Strategy.
- Ensure development, challenge, validation, communication, and execution of new product and lifecycle regulatory strategies for products under responsibility, in collaboration with regional stakeholders including commercial, market access, medical, and global stakeholders leads.
- Lead regulatory activities to ensure early stage development requirements highlighted and considered by RDPL/PDC teams , as part of development and submission strategy.
- Engage with asset team subject matter experts to oversee, direct, and steer preparation of China specific briefing documents, supporting documentation, and resource planning.
- Ensure development, discussion, and cross line agreement of nascent regulatory/development strategies and support of subsequent endorsement discussion with senior stakeholders including PDC-OC.
- Identify opportunities to build and enhance relationships with key external stakeholders and Regulatory Agencies in alignment with Regional Team (UK/China) and Reg. Policy.
- Ensure Regulatory representation and company policy aligned input to country industry associations, whilst ensuring alignment with local business colleagues.
- Direct and provide consolidated Global Emerging Markets input and insight to development teams, to ensure development considerations are considered as part of the development program.
- Gain agreement for submission prioritization and resourcing with the PDC, working closely and directing company regional colleagues, and for oversight of company submissions.
Skills and Requirements:
- Scientific degree (molecular biology or medical doctor).
- 3 years of relevant working experience in oncology medical affairs.
- Extensive knowledge of all aspects of drug development, GCP, and regulations.
- Successful experience working in a matrix team environment.
- Understanding of marketing principles and strategies.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.