Senior Regulatory Affairs Manager - CMC x2 - United Kingdom
As Soon As Possible
- Proactively manage assigned Regulatory CMC (Chemistry and Manufacturing Control) and compliance activities.
- Provide CMC strategy, advice and information to RA Strategic Team leaders; internal departments, Associated Companies and Licensees.
- Provide CMC input on development project strategies and provide support to ongoing development projects.
- Take a high level of personal responsibility and accountability for managing and delivering complex Regulatory projects, for problem solving, and business critical decisions.
- Project manage and lead tasks, which may have a high degree of impact to the business.
- Decide on the strategy to address any CMC specific questions from Regulatory Agencies, Associate Companies, other Regulatory Affairs personnel as required.
- Assist with the maintenance of all MA’s via renewals and variations by preparing the required documents.
- Provide expert scientific advice on items or issues which affect the Company both in the present and strategically. Thinking and working strategically to develop the business.
- Evaluate and assess due diligence activities and Business Development projects for Regulatory CMC and report to Senior Management to tight timelines.
- Build and maintain relationships with all departments and network with other functions within the region to ensure effective communication and efficient implementation of regulatory activities e.g. independent companies, partners, licensees, and authorities.
- Evaluate the impact of new regulations on the Mundipharma business and undertake appropriate action.
- Be responsible for the content of the module 2.3 (QOS) and be responsible for the expert report.
- Line management, mentoring, providing guidance and support to other team members including advising junior staff on data requirements for their activities.
- Ensure appropriate training and development of staff. Evaluate performance of regulatory staff on an ongoing basis and take appropriate steps to address any issues.
- Assist with team development and supports the senior management where appropriate.
- Act as role model for the Company values and leadership attributes, in particular demonstrating vision and strategic focus, being inspirational, awareness of bigger picture, flexibility.
- Prepare state of the art, compliant CMC documentation to support clinical trial applications, marketing authorisation applications and product life cycle maintenance via renewals and variations in accordance with any applicable regulatory guidelines and good regulatory practice and where appropriate, using the electronic document and data management system.
- Carefully review and check all information received to determine any errors or omissions and arrange for the provision of amended/additional data.
- Create, manage and circulate documentation for review and approval by appropriate functions and Marketing Authorisation Holders to ensure company compliance.
- Respond directly to questions from associate companies regarding CMC registered information.
- Provide advice and support with regard to changes to CMC information via the change control procedure. Develop a strategic implementation plan with RAST leader.
- Ensure all relevant project/product related information is retained and applicable technical information is recorded as specified in departmental procedures.
- Take a high degree of personal responsibility for representing the Company both internally and externally.
- Maintain records of tasks and provide any relevant registered information for inputting into the Regulatory Affairs Department database.
- Raise issues with the appropriate Regulatory Affairs team members and perform actions to address these issues, as agreed.
- Work as a team player and perform all reasonable tasks related to regulatory activities according to the agreed schedule and priority.
- Develop and document new working practices and ensure that department procedures are followed.
- Take responsibility for personal training and development in order to reach and maintain the required skills, knowledge and experience to perform the role.
- Has an in-depth knowledge of technical and scientific information, legislation and relevant Regulatory Guidelines and can assess their impact on the business.
- Possesses exceptional written and oral communication skills.
- Qualified to degree level in a scientific subject or equivalent, or HND or equivalent industry experience where appropriate
- Is IT literate, particularly in relation to using databases and document management systems
- Comprehensive breadth of technical regulatory experience (Development & Post-Approval).
- Working unsupervised and leading others.
- Acting as line manager, coach and mentor to other staff.
- Representing the company and negotiating/influencing with internal and external bodies.
- CP/DCP/MRP National procedures.
- Preparation of IMPD/IND/M2.3/M3.
- Positive work style, with an approachable, flexible manner, excellent analytical and problem-solving skills, and has a high attention to accuracy and detail.
- Working to strict deadlines and managing own time.
- Building effective working relations internally and externally and being an active team member.
- Succeeding in delivering large complex projects.
|Adress:||Mundipharma Research Limited |
Cambridge Science Park