Job Description
This is a rare opportunity to gain experience in regulatory submissions for worldwide markets with direct contact with local regulatory affiliates. The role of Senior Specialist Tech Ops Global CMC Regulatory is a key contributor to the company’s growing business and requires a self-starter, with a high degree of agility. The person appointed will engage directly with subject matter experts, site manufacturing leadership teams as well as alliance partners.
With strong expertise in post approval lifecycle management, the Senior Specialist TechOps CMC-Regulatory Strategy will have responsibility for the coordination of CMC (Chemistry Manufacturing and Control) Regulatory activities, to include geographical expansion, of commercially approved products as assigned by the Director TechOps CMC-Regulatory Strategy.
- Develop the TechOps CMC-Regulatory strategy and create a proposed implementation plan for regulatory submissions and obtain agreement from all relevant stakeholders
- 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
- Review technical documentation supplied by Subject Matter Experts for completeness and accuracy
- Liaise with Subject Matter Experts and write 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
- Monitor and manage risk in routine TechOps CMC-Regulatory activities
- Review of Change Controls for assigned products, document and clearly communicate any Regulatory impact and CMC-Regulatory requirements
- Anticipate any gaps in planned regulatory submissions and new registrations taking into account emerging regulations and country specific requirements
- Work effectively with Alliance Partners as required to support and prepare CMC-Regulatory submissions
Work with Global Regulatory Affairs (GRA) Therapeutic area, GRA Intercontinental, and GRA Regulatory Operations teams to ensure that CMC-Regulatory submissions are compliant with group policies and procedures and are planned and scheduled appropriately to align with Technical Operations implementation requirements while ensuring adequate time for review, approval and publishing tasks
- Perform CMC-Regulatory Intelligence activities as required and work with cross-functional departments to ensure related operations are compliant
- Prepare the CMC section of US Annual Reports and liaise with relevant subject matter experts as necessary ensuring on-time completion through efficient coordination with GRA US.
- Coordinate updates to the Registered Site Master File for company Manufacturing Site as required
- Responsible for maintenance of company Manufacturing Site Regulatory Licenses, Site Registration and Site Accreditation documentation as applicable
TechOps CMC-Regulatory Strategy point of contact for on-site Regulatory authority inspections and paper inspections where applicable
Education:
- Degree/Masters in Pharmaceutical /Biological/Chemical Science or relevant scientific discipline
- Languages: Fluent in English, French would be a plus
Experience (Proficiency):
- At least 5 years work experience in multinational Life Science companies with relevant experience in the preparation of Module 2.3 and 3 Regulatory documentation for small molecules and/or biologicals is essential.
- Experience should include clinical development (IND/IMPD), registration and post-approval activities in US, EU and major Intercontinental markets e.g. China, Japan. Experience with medical devices is a plus.
- Demonstrated experience in the development and implementation of CMC-Regulatory strategies for major regulatory submissions
- Understanding of Quality activities and assessment of cGMP compliance, site registration and licensing
- Experience in stakeholder management
- Experience in working in international environment / global organisation
- Excellent critical thinking, presentation and communication skills
- Internal and external contacts (organisation):
- External: Regulatory Authorities, Alliance partners, vendors, contractors, industry associations
- Internal: CMC-Regulatory teams, Global Regulatory Affairs, Global Quality, Manufacturing, Local Quality, Pharmaceutical Development, Local Regulatory Affairs
- People management: Not applicable
Cv to gerry@rftgroup.ie