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Associate Director Global Regulatory Affairs
1 month ago
The following information aims to provide potential candidates with a better understanding of the requirements for this role.
At Norgine, our colleagues
Dare
themselves to be different and try new things,
Drive
to achieve their goals and beyond, and
Develop
themselves and their community.
We call it the
3D career
at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do.
Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.
We have an exciting opportunity for an 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.
KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
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.Requirements
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.This job description is a summary of the typical functions of the job; not an exhaustive or comprehensive list of all possible responsibilities, tasks and duties. Norgine reserves the right to change responsibilities to meet business and organisational needs as necessary.
Benefits
Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
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