JOB SUMMARY
Primary purpose & key accountabilities
• Accountable for supporting regulatory CMC submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets including HA query management.
• The main focus is on complex site transfers, legal entity name changes and other multi-market projects.
• Ensures transparency and excellence in evaluation, definition and execution of regulatory strategies.
• Applies knowledge and interpretation of regulatory requirements to enable efficient and effective approvals consistent with global supply and commercial objectives.
• Proactively builds cross functional relationships and ensures communication/clarity of regulatory timelines and strategy.
• Ensures dossiers are produced and dispatched to assigned markets according to their defined filing plan and are submission ready.
JOB RESPONSIBILITIES
Primary responsibilities critical to the role
• Profound understanding of local regulations, regulatory processes and requirements across EU, UK, CH, EME, Australia, New Zealand, Canada, Korea with an ability to translate these into product strategies and business processes.
• Ensures uncompromised compliance in line with corporate policies and procedures
• Delivers submissions through collaboration in line with corporate culture and values.
• Effectively manages regulatory activities and drives issues to resolution in a timely manner.
• Enables post approval strategy and execution in collaboration with key partner lines to ensure a submission ready dossier.
• Inputs into projects teams on key technical issues and suitability of technical information to meet regulatory agency expectations.
• Ensures efficient and timely communication and effectively communicates the regulatory position
• Authors local submission components as needed.
• Ensures right first-time approvals – reviews submissions against local requirements for consistency and completeness as needed.
• Co-ordinate with global strategists the receipt, distribution, and response to regulatory queries.
• Works collaboratively across the regulatory organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
• Cultivates positive and professional relationships.
• Holds self-accountable for results and commitments.
QUALIFICATIONS / SKILLS
Technical Skills
• Profound understanding of the IDM regulatory environment (EU, UK, CH, EME (Serbia CBC Cluster, Ukraine, Israel, Palestine), ANZ, Canada, Korea)
• Demonstrated expertise in managing complex site transfers
• Technically competent to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks
• Significant knowledge of drug development practice, rules, regulations and guidelines
• Strategic and analytical thinking
• Communication skills
• Team working + collaboration
• Strong quality and compliance orientation
• Fluent in English – written and spoken communication skills
Qualifications
• Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science
• MSc, MBA, or PhD may be an advantage
• Prior experience in the pharmaceutical industry in Regulatory Affairs, Conformance or Compliance
• Profound knowledge / background of IDM regulatory procedures and requirements
Experience
• Minimum 8 years of regulatory or compliance experience
• Proven regulatory experience in managing site transfer activities across IDM markets/regulations
• Demonstrated experience of effective delivery in a cross functional environment
• Proven ability to mitigate regulatory challenges and consistently deliver to time and quality standards