Head of regulatory and Compliance

Job Reference: fm113472

Job Duration: 12 Months

Start date:

Description:

Head of regulatory and Compliance
Location: King's Lynn, Norfolk
Duration: 6- 12 month FTC (with possibility of extension)
Salary: 65-75k annually
Role Purpose:
To provide strategic regulatory expertise and oversight to support the design, development and commercialization of products.
To lead the Regulatory Affairs function within the company, ensuring the service is efficient and successful in providing regulatory guidance and in meeting our clientsRegulatory needs
To partner with those clients to ensure a mutually beneficial regulatory strategy for new productsTo keep abreast of regulatory changes and their applicability to the business and conduct impact assessments proactivelyAct as a figurehead for the Quality function, leading by example and championing the Core Values in all activities and interactions undertaken.
Key Accountabilities:
Partner with the Director of Quality and Regulatory Affairs to alignon the regulatory strategy for all product(s) and ensure they are consistent with The company (and Group) portfolio strategy.Provide critical review and input on device (design) area or portfolio regulatory strategies, risk planning and mitigations.
Represent the regulatory function in senior level interactions at internal governance, technical review committeesor steering groups, deputizing for the Director of Quality and Regulatory Affairs as required to ensure business (and client) needs are met.
Work in collaboration with regional policy and intelligence groups to critically analyze the assessmentof emerging science/technology, data and changes in the regulatory environment and advises senior management on project risks/mitigation activities accordingly.
Provide effective strategic technical guidance to cross-functional submission teams. This includes overall data interpretation, conclusions, key messages, registrational strategy and potential mitigation strategiesfor risks that may exist.
Provide leadership and direction to all reports ensuring personal development plans and succession planning pipelines are in place and regularly reviewed and that a culture of continuous learning is promoted and maintained.
Coach direct reports to improved individual, as well as team, performance, ensuring appropriate, constructive andfrequent feedback is maintained.
Ensure submission excellence framework is consistent applied across projects and programmes, including knowledge sharing and leveraging appropriate tools.
Lead (and host) all internal and external Regulatory Audits and investigations to ensure conformity to regulatory and company compliance.
Proactively pursue continuousimprovement opportunities within the established Regulatory Affairs processes.
Decision Making and Influence:
Objectives are led by Company Strategy and will be reviewed on a regular basis. Minimal direction is provided.
Role holder needs to apply effective judgement and decision-making in complex business critical situations, escalating issues with significantrisk/implication to Director of Quality and Regulatory Affairs
Role holder will foster a work place culture within that prioritizes the health, safety, and well-being of its employees; the quality of our products and a customer focused approachfrom all team members.
Able to interpret new and changing regulations to ensure that the company is not under or over regulated.
Role holder needs to maintain effective working relationship with Regulatory bodies, e.g. FDA, MHRA & Health Canada. Key Regulatory contact for the company, customers and regulators.
Attributes, Competencies, Knowledge and Skills:Strategic leadership skills, with a deep understanding of regulatory frameworks, overall device development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders
Able to deal with constantly changing priorities.
Bachelor's degree in life sciences and/or science related field and/or other appropriate knowledge/experience
Excellent collaboration, team working, oral and written communication skills
Must demonstrate competencies of strategic influencing (of key stakeholders/leaders), innovation, initiative, and leadership
Experience in EU & USA Regulatory Filing processes for Medicines and Medical Devices through product life-cycleincluding injectables, nasal and oral pMDI combination products.
Please do not hesitate to get in touch fabiola.mobou@secpharma.com or via +44 (0)20 7255 6600.

Industry: Pharmaceuticals

Salary:

Salary Benefits:

Vacancy Type: Contract

Job Skills: -

Contact Name: Fabiola Mobou

Website: -

Direct Application URL: -