Associate Director Global Regulatory Affairs

Griffin Fire; Uxbridge; On-site; GBP 150,000 - 200,000

Job description

Want a 3D Career? Join Norgine.

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.

The core responsibility of the 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:

• 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.
• Leadership for all meetings and communications with regulatory agencies; providing regulatory advice and recommendations to the project team and 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 lists of questions; responsible for leading complex regulatory tasks/procedures; overseeing vendors/regulatory service providers; reviewing and/or approving regulatory documents/submissions for medicinal products; budgetary responsibility as required.
• Represent Regulatory within and external to Norgine; including interaction with industry trade associations, lobbying groups, and external consultants for regulatory policy and intelligence purposes.
• Being the regulatory point of contact and regulatory Lead for the project team; leading all regulatory activities to ensure all regulatory tasks associated with the project are completed as per project timelines.
• 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 the external regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends.
• Extensive knowledge of the drug development process, including early-stage drug development, CTAs, orphan designations, PIPs, etc. Good knowledge of 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 is an advantage.
• Line management; including staff recruitment, people, and performance management is an advantage; however, on-the-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 the 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 is 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.

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.