This role will ensure that pharmaceutical products are developed, manufactured, and distributed in compliance with all U.S. applicable regulatory requirements and standards. The Regulatory Affairs Associate Director serves as a strategic partner across cross-functional teams, providing regulatory strategy and guidance throughout the product lifecycle — from development to marketing approval and post-approval surveillance. This role is critical in securing timely application approvals from the FDA, maintaining product compliance, and supporting the company’s commitment to patient safety and product quality. Use the ‘general responsibilities and skills and qualifications’ for the rest of the advert.

The Quality Manager is responsible for leading the quality assurance functions for Sabal Therapeutics and its client companies. This role will commence with an evaluation of company GMP Quality Systems and gap analysis. Creation and implementation of necessary processes and procedures will be an integral part of the first six months. Oversight of third party CMO activities, outsourced packaging facilities and API providers as well as on-going product release, change control, CAPA, employee training and vendor auditing are key functions of this position.

The CMO Purchasing Planner has the primary responsibility of raising and managing purchase orders consistent with forecast requirements. Working closely with Quality, Commercial and Suppliers, to ensure the timely delivery of Contract Manufactured Finished Product into the business, according to the correct quality and specification. Adhering to current working practices and KPI measures, monitoring performance and addressing internal and external queries.

Ensures Quality Assurance activities are planned and executed in line with Rosemont SOPs and GMP Requirements and Regulations

Ensures that company products meet defined quality standards through leadership of product auditing and product release groups. The incumbent oversees review and approval of SOPs, deviation investigations, CAPA management, Change Control management and APRs. Maintains quality systems and works collaboratively with other site functions to drive improvement and enhance quality culture whilst upholding the Rosemont values.

As a member of the Quality Leadership team the post holder will contribute to the creation, execution, review and evaluation of the Functional strategy for their business area. They will additionally feed this insight into our long-range strategic planning process. In collaboration with cross-functional colleagues, they will then ensure the effective implementation and execution of key strategic deliverables.

Working with leadership colleagues, the post holder will drive our purpose and evolve our culture to ensure we sustainably improve the lives of our patients in everything we do every day. They will further role model our values and help ensure Rosemont remains a great place to work.

Responsible for leading the cross-functional management of the due diligence team supporting both BD and
M&A initiatives. Will drive projects through from early-stage screening to deal execution, managing timelines,
project planning, risk assessment and reporting.

Independently contribute and/or oversee the required risk assessments and if necessary, develop and validate suitably rugged Extractable and Leachables and Nitrosamine methods of analysis. Also Independently contribute and/or oversee the development and validation of physical and chemical analytical methods that will determine all necessary product parameters including physical characteristics, determination of active, degradation products, preservatives, volatiles using the most suitable analytical instruments available to the company in compliance with standard operating procedures and international scientific, quality and regulatory standards. Provide analytical development support to the business for problem solving and lead continuous improvement projects. Ensure analytical methodology is suitably rugged and fit for its intended purpose. Provide supervision, training, technical development and performance evaluation (periodic and annual reviews) to direct reports and other staff members as appropriate. Independently evaluate emerging technologies, systems, and work methodologies to support the continuous improvement of operational practices. Contribute data-driven insights to inform return-on-investment analyses and enable the adoption of innovative and efficient solutions across the organisation. Deputise for the Manager when required.

Responsible for overseeing the seamless transfer of pharmaceutical products, processes, and technologies from R&D to manufacturing or between manufacturing sites, including from CMOs. This role ensures that all technical, regulatory, operational and quality requirements are met to support successful product launches and lifecycle management.

To liaise with minimal supervision, with 3rd party product developers and 3rd party manufacturers. to successfully technical transfer (TT) to the receiving unit. To provide Support and Technical expertise to the Quality unit to for the transfer of analytical methods. To ensure analytical methodology is suitably rugged and fit for its intended purpose.

To develop the skills and experience necessary to become a competent maintenance and facilities engineer within a pharmaceutical workplace. To support activities that ensure the reliable and safe functioning of all equipment in order to achieve efficient, effective & compliant operations.

To support site facilities activities and the implementation of some capital expenditure projects. To understand pharmaceutical regulations and guidance and appreciate how they are applied throughout all site activities.