Associate Director, Regulatory Affairs Innovative Medicine - London, United Kingdom - Lifelancer

Description

ADVANZ PHARMAs product portfolio and pipeline comprises innovative medicines, specialty generics biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.
About the Role

• As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Associate Director Regulatory Affairs.
• The Regulatory Affairs Innovative Medicines - Associate Director will provide strategic regulatory and scientific support on pre-clinical and clinical development plans and work with both Regulatory Affairs New Products and Regulatory Affairs -Life cycle management teams with an objective of getting fast access of innovative medicines to patients in the most efficient way.
• This will encompass Regulatory strategy planning, supporting due diligence assessment for any innovative assets (for study adequacy, and data presentation, risk analysis), leading or supporting any regulatory interaction on Clinical development pathway with internal and external stakeholders including health authorities working closely with Medical office, contribute actively to the review of Clinical/Non Clinical overview/summary reports and support rest of Regulatory organisation during Marketing Authorisation Application and Life Cycle Management for products approved on the basis of extensive clinical development plans.
• This highly visible and influential role will involve exposure to Senior and Executive Management and requires an individual with a collaborative approach and the ability to link with and influence others.

What Youll Do:

• Strategy Planning The role will actively contribute to strategic decision at all life cycle stages of any innovative medicines in the ADVANZ portfolio this will involve (but not restricted to):
• In collaboration with the clinical team, assess adequacy of the clinical data package for regulatory submission based on available scientific guidance, precedence, previous experience and any scientific communication with any health authority if available specific to the clinical program; seek clarification from developer to make informed decision; work cross functionally to assess risks/mitigation; assess need/topics that may benefit from any further regulatory HA interaction.
• Contribute to the preparation of clinically oriented briefing packages for Scientific Advice/Protocol assistance; represent ADVANZ regulatory in any such discussions.
• Contribute actively in development of any future clinical development plans working closely with medical office and regulatory new products team to support the MAA (specifically regulatory strategic considerations like non-clinical data package required to support MAA, clinical study protocol study population, dose selection, study endpoints, interim analysis plan etc like )Design of Phase 3 trials, Post Approval Safety/Efficacy Study, Paediatric programs or any other specific obligations for Conditional Marketing Authorisation Application
• Regulatory Review- The role will actively be involved in review of study synopsis, study protocol, Module 2.4, 2.5, 2.6 and 2.7 and will be responsible/accountable for correctness and adequacy of these sections. The role will work collaboratively with internal stakeholders (Medical Office at ADVANZ PHARMA, Market access/commercial when applicable), external stakeholders (Developer/Licensor organisation and their regulatory partners) and Regulatory New product Project manager to finalise the documents for submission. The role will also be responsible for review of product label (SmPC). The role will also be responsible for contributing to the response strategies to any questions from health authorities during a regulatory procedure.
• While we do not expect to run clinical trial applications by ourselves, ADVANZ may be the sponsor for any new or ongoing clinical trial, in which situation this role would be expected to keep an oversight and/or manage Clinical Trial Applications working collaboratively with the designated CRO.
• Other responsibilities (not limited to)
• Work very closely with Associate Director Regulatory Affairs New Products and Associate Director(s) Regulatory Affairs Life cycle Management (UK/IE, EU and ROW) in supporting regulatory deliverable where there is a active dependency on clinical data package
• Work very closely with Transformation Office Strategic Program Managers and Regulatory Affairs New Product Project manager for Alliance Management of the relationship with all new partners and their regulatory departments to ensure timely feedback to all queries.
• Work very closely with Clinical, Medical Affairs and Patient Safety leadership within Medical office
• Actively participate and contribute in regulatory organisation team meetings, New product Introduction governance meetings to provide relevant updates, proactively flag risks and propose mitigation alternatives to facilitate fast decision making as applicable
• Support and actively contribute to internal training and development of Regulatory organisation, keep an active lookout for changing regulations and bring the organisation up to speed with any such changes and its impact.
• Escalate risks / issues appropriately to remove barriers to success or advise of delays and other changes which may impact the regulatory approval timeline.
• Propose improvements or alternative approaches to obtain improved project deliverables.

About YouWe are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives.For this role, you will also have the following:
Qualifications:University degree in a scientific disciplineAdditional Regulatory professional qualifications
Experience Competences:

• Regulatory role in submission of New products in Pharma Industry (at least 15 years +)
• Significant understanding and experience preparing Common Technical Dossiers
• Relevant and current experience in submissions/managing of National and European MAA and support product launches
• Experience working with New Chemical Entities applications preferably Phase 2/3
• Experience working with Generic and Biosimilars applications
• Experience interacting with EU regulatory authorities Scientific advice meetings/ Pre-submission meetings
• Experience handling PIP applications and orphan designation
• Experience managing Clinical trial applications
• Experience in Medical Devices and their clinical evaluation
• International Regulatory experience specifically USA

Knowledge Skills:

Broad knowledge and awareness of the European regulatory guidelines and legislation and idiosyncrasies in multiple markets. Strong understanding of Drug Development process. Understanding on early development programs which includes non-clinical studies (PD, PK and toxicology) will be a good add on An excellent understanding and first-hand working experience on clinical development programs supporting successful NCE registration in EU and UK. Experience with rare/orphan diseases challenges associated with RCT, first hand experience on using alternative sources to prove benefit evidence including indirect sources Use of electronic portals for dossier submissions; Good working knowledge of Regulatory IT systems Strong project management skills; ability to work in a matrix fashion with matrix objectives is a must Excellent communication and interpersonal skills Effectively able to communicate at leadership level; positive executive presence.

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