Lead/Associate Manager

Responsibilities:

• Responsible for the Module 3/CMC related Life Cycle Management (LCM) activities of assigned products and projects providing regulatory assessments and deploying regulatory technical content globally, providing regulatory input and technical guidance on regulatory requirements to Life Cycle Management Teams (e g manufacturing site representatives) within the Smoking Cessation franchise (OTC medicinal products).
• Coordinating and closely supporting a team of RA CMC contractors in their daily work managing the following activities;
• Conduct regulatory impact assessments of CMC related change controls affecting products registered globally
• Clearly convey outcome of regulatory impact assessments to relevant life cycle management team members
• Authoring and dispatching fit-for-purpose CMC documentation for submission of regulatory change applications by local regulatory affiliates
• Actively follow up with local regulatory affiliates on regulatory change status
• Responsible for the review of the regulatory deliverables from the contractors, including ensuring there is an efficient peer review process within the team
• Responsible for team member compliance with regard SOP trainings, audits etc
• Responsible for constructively critiquing and improving the team deliverables

Essential Duties:

• Serves as a CMC lead for the deployment of CMC regulatory technical content, submissions and compliance activities for Self-Care medicinal products within Smoking Cessation franchise.
• Provides and supports technical and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities.
• Lead the preparation of CMC information for submission to global regulatory agencies, generates and deploys CMC technical content, assesses risks and develops contingency/mitigation plans.
• Acts as the global/regional CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for technical CMC decisions.
• Escalates and aligns with manager on topics requiring acceleration, facilitation and/or prioritization of actions/work needed from the team and for managing subsequent required discussions with cross-functional life cycle management teams and external partners accordingly.
• May represent CMC during interactions with internal and external partners either directly or in conjunction with Global Regulatory Affairs Teams.
• Resolve issues and manage regulatory risks within project teams. Investigates opportunities for regulatory improvement / promote the use of novel approaches within project team to resolve issues and problems.

Essential knowledge and skills:

• Relevant bachelor's degree or higher
• Minimum of 8 : 10 years of relevant work experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables.
• Superior knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
• Proficiency in managing LCM CMC changes related to drug products containing chemical API towards EU Health Authorities in accordance with EU regulations for variation management. Similar skills pertaining to US, CA, Latin America and Asia-Pacific are beneficial.
• Sufficient level of knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage forms in addition to manufacturing and regulatory data requirements for managing Global post approval submissions.
• Knowledge in retrieving information from company's and regulatory agency databases.
• Good level of knowledge on general standards, processes and policies around manufacturing medicinal products.

Core competencies

• Proficiency in English
• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.