Job Title: Expert CMC Regulatory
Division / Function: Global Regulatory Affairs – CMC Regulatory
Manager (Name, Job Title): Senior Manager, Director, or Senior Director CMC Regulatory
Location: Ipsen location in France / Ireland / UK
Summary / purpose of the position

• Prepare the CMC regulatory strategy for assigned projects under the strategic direction of Manager/ Director
• Contribute to the generation of effective CMC regulatory dossiers aligned with defined roadmaps to optimize time to market of new and existing products in global markets (initial submissions, geographical expansion, and life cycle management).
• Contributes to the regulatory intelligence process

Main responsibilities / job expectations
CMC Regulatory strategy

• Contributes to the data collection supporting building of the CMC regulatory strategy. Contributes to the drafting of the CMC regulatory strategy roadmaps.
• Anticipate any gaps in planned regulatory submissions and new registrations and respond independently to requests for information.
• Contributes to collect regional regulatory specificities & needs and incorporate these into the global plans.
• Monitor identified risks in CMC-Regulatory assigned activities.
• Participates in coordinating the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Contributes to the development and maintenance of efficient, compliant and robust systems, procedures and processes.

CMC dossiers preparation

• Contributes to deliver (coordination, authoring and review) effective, timely and compliant CTA (IND, IMPD) and MAA modules 1, 2 & 3 in the correct format “Ready For Submission” for new and existing products in compliance with e CTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required. Collaborates mainly with teams and Subject Matter Experts (SME) in Pharmaceutical Development, Tech Ops, non-clinical, GRA, LRA.
• Compile regulatory technical documentation including updating CTD sections with process and analytical data extracting information from reports, batch records, analytical procedures and quality events as appropriate.
• Participate in the review of technical documentation supplied by Subject Matter Experts (SMEs) for completeness and accuracy.
• Work with Global Regulatory Affairs (GRA) Therapeutic area and GRA Regulatory Operations teams to ensure that CMC-Regulatory submissions are compliant with Ipsen group policies and procedures and are planned and scheduled appropriately to align with global planning and implementation requirements while ensuring adequate time for review, approval and publishing tasks.
• Liaise with SMEs and participate in the authoring of Regulatory Response to Questions while thinking critically.
• Ensure questions from Regulatory Authorities for our global markets are responded to efficiently and on-time in order to meet expected submission approval timelines.
• Prepares and maintains the necessary CMC writing trackers, monitor progress and provide regular updates to the team.
• Prepare the CMC section of US Annual Reports and liaise with relevant SMEs as necessary.
• Preparation of Rest of World Site GMP registrations and Site Accreditation documentation for both an Ipsen site and a contract manufacturing site

Regulatory intelligence

• Contributes to Regulatory intelligence, by tracking and analyzing the evolution of regulations relative to CMC topics.
• Communicates key regulatory CMC related guidance’s to SMEs and other stakeholders within Ipsen.

Communication & Compliance

• Support the review of Change Controls for assigned products and the identification of any Regulatory impact and CMC-Regulatory requirements.
• Perform updates to the Registered Site Master File for an Ipsen Manufacturing Site as required.
• CMC-Regulatory Strategy point of contact for Ipsen site Regulatory authority inspections and paper inspections where applicable.
• Ensure that product master binders in the electronic document management system and/or fileshare system are maintained as current.
• Work effectively with Ipsen Alliance Partners to support and prepare CMC-Regulatory submissions.
• Ensures adequate reporting of his/her activities and participates to various meeting.
• Supports and voices the regulatory position consistent with the CMC regulatory strategy validated by senior management.
• Actively contributes to the Regulatory Community life. Supports transversal projects within GRA.
• Contributes to the review of company systems and processes.
• Operates according to Regulatory and Ipsen procedures.

EHS Responsibilities

• Complies with applicable EHS regulations and procedures.
• Participates in the site’s EHS performance by reporting risks, malfunctions or improvements.
• Participates in mandatory EHS training.

Knowledge, abilities & experience

Education / Certifications:

• Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science)

Experience:

• Minimum 3 years direct experience in CMC regulatory R&D environment in pharmaceutical industry.
• Small molecule and/or biological experience

Languages:

• Fluent English
• French preferred

Key Technical Competencies Required

• Previous experience in CMC regulatory field in a worldwide environment
• Previous technical and regulatory writing experience with pharmaceuticals and familiarity with e CTD formats and publishing support functions.
• Understanding of Quality activities and assessment of c GMP compliance, site registration and licensing
• Ability to work in a cross-functional global environment and experience in stakeholders management.
• Excellent written, verbal and interpersonal communication skills, highly organized
• Ability to handle multiple priorities and complex projects in a fast-paced environment.
• Analytical mindset and excellent attention to detail
• Problem-solving skills