This is a global role with an initial primary focus on EMEA and Asia Pacific markets. Global brand under the supervision of the Manager, and as a representative of the Global Regulatory Affairs organization.
Key Responsibilities
Partner with R&D, QA, Operations, Business Units and other stakeholders to develop regulatory strategies for health authority submissions or other product related activities.
Contribute to and implement regulatory strategies to ensure documentation is available for filings (eg, New product registrations, Variations, Responses to Questions), as appropriate.
Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc) with filings and propose CMC mitigation strategies.
Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data/documents in accordance with project timelines.
Write high-quality CMC documents, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines.
Preparation, review, submission, approval, and maintenance of CMC sections for regulatory filings (CTA s, MAA s, variations, renewals, etc)
Review post-approval changes (change controls), assess the regulatory impact on affected registrations and provide CMC support to write/collate relevant variation packages.
Work collaboratively with global CMC colleagues and as required, provide supervision of CMC support to them.
Provide input to refine/develop processes relating to regulatory submissions and regulatory aspects of product development and maintenance.
Train and educate colleagues/business partners with respect to regulatory requirements.
Assist in overseeing CMC activities performed by colleagues/business partners
Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
Promote regulatory intelligence in both local and regional initiatives
Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
Keep up to date knowledge of quality guidelines and technical trends
Represent company in industry organizations, seminars, workshops, etc (as assigned)
Required Qualifications
Minimum B.S. Chemistry, Pharmacy or related scientific field.
Preferred 5+ years of relevant work experience
Working knowledge of regulatory requirements, particularly for EU and other countries, (Asia Pacific, Middle east etc) for various drug dosage forms including solids, semi-solids, solutions, sterile products, etc Experience of regulatory CMC requirements for other global regions is beneficial.
Experience in preparation and maintenance of CMC sections for Health Authority filings (Modules 2.3 and 3, CTD, e-CTD); experience with global dossiers is desirable
Experience with documents needed to support local, regional, and global filing requirements.
Awareness of consumer product categories (eg, drugs, cosmetics, devices).
