Associate Director Global Regulatory Affairs

Associate Director Global Regulatory Affairs

Norgine

Uxbridge, United Kingdom

We have an exciting opportunity for a Associate Director Global Regulatory Affairs to join Norgine. The person holding this position will report to the Director Global Regulatory Strategy Science and Evaluations and be a member of the Development team.

The core responsibility of the of Associate Director Global Regulatory Affairs is the Strategic and operational leadership of all regulatory development activities associated with his/her team and/or those projects under his/her responsibility. This will be a permanent role.

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO

To act generally on behalf of all Norgine legal entities, including:

• Creation of regulatory strategy in line with project plans; responsible for the regulatory strategy for the project and creating regulatory solutions to complex project challenges;
• Communication: leadership for all meetings and communications with regulatory agencies; providing regulatory advice and recommendations to the project team, senior management in relation to development programmes; clear leadership in the relationship with vendors/ regulatory service providers;
• Execution and delivery of operational regulatory activities such as submitting new MAAs and responses to list of question, responsible for leading complex regulatory tasks/procedures; overseeing of vendors/ regulatory service provider; reviewing and/or approving regulatory documents/submissions for medicinal products; budgetary responsibility as required;
• Influencing and advocacy: represent Regulatory within and external to Norgine; including interaction with industry trade associations, lobbying groups and external consultants for regulatory policy and intelligence purposes;
• Direction and leadership: being the regulatory point of contact and regulatory Lead for the project team, the regulatory lead from the regulatory service provider perspective; leading all regulatory activities to ensure all regulatory tasks associated with the project are completed as per project timelines;
• Compliance: ensure compliance with Norgine regulatory/quality processes and support with inspections and audits where required.

SKILLS & KNOWLEDGE

Knowledge/experience:

• A strong scientific background evidenced by a combination of qualifications (educated to degree level in a life sciences subject), continuing professional development (e.g. TOPRA membership or similar) and considerable relevant experience;
• In-depth understanding of external regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends;
• Extensive knowledge of drug development process, including early stage drug development, CTAs, orphan designations, PIPs etc. Good knowledge of the drug life-cycle management processes; regulatory operations and systems;
• Extensive European regulatory knowledge and experience; of which a considerable amount gained from operating at a senior level in research and development-based pharmaceutical companies/regulatory consultants and/or regulatory authorities;
• Experience in working with external partners in drug development projects and/or due-diligence evaluations of new product opportunities;
• Experience of and appropriate training in GxP. Experience with regulatory inspections and audits an advantage;
• Line management; including staff recruitment, people and performance management an advantage, however on job training & support is available.

Skills:

• Professional integrity at all times, embracing a culture of continuous improvement built upon personal foundations of honesty, resilience and commitment to quality, with an ability to build trust with both peers and senior stakeholders;
• Excellent regulatory skills; strong presence with ability to command respect, exercising effective decision making and judgment. Has the credibility to influence relevant internal and external stakeholders;
• Demonstrable problem-solving skills with adaptability, agility and flexibility of approach in working with others. Assesses complex concepts and detailed data to quickly grasp the “essence” of a situation and applies critical thinking to resolve problems;
• Communicates persuasively and productively to inform or influence others, whilst also being receptive to the views of the wider team, adapting own position as new evidence or new perspectives arise;
• Able to work successfully both as a team in a matrix organisation and independently with minimal supervision and can accommodate multiple activities to agreed deadlines.
• Good oral and written communication skills; communicates effectively in English, with other European language skills an advantage;
• Good computer literacy with working knowledge of Windows, Microsoft Office and the EMA regulatory portal an advantage;
• Excellent networker, builds strong relationships with others internally and also externally to advance knowledge and enable higher performance;
• A positive attitude with the drive, determination and desire to move activities forwards; adding value and contributing to the overall growth of the Norgine business.

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