ABOUT YOU

We 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 discipline
• Additional 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

ABOUT THE ROLE

The Regulatory Affairs Innovative Medicines - Associate Director will take on the role of a Global Product Lead (IM)and be responsible/accountable for all regulatory activities (pre-submission, MAA and post approval) of assigned portfolio of Innovative Medicines. This role will provide strategic regulatory and scientific support on non-clinical and clinical development plans and work with both Regulatory Affairs – Strategic Project Leads 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 role will be the regulatory point of contact for any Innovative asset as assigned to the rest of the organisation.
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 non-clinical and clinical development pathway with internal and external stakeholders including health authorities working closely with rest of Medical office, contribute actively to the review of Marketing Authorisation Application (acting as an Regulatory SME on Clinical/Non Clinical part of the application) and work closely with Strategic Project Team under New products during the Marketing Authorisation Application review. This role will also be responsible for developing life cycle strategy and all post approval activities (working closely with LCM team) specially while there are open non- clinical/ clinical commitments/obligations to fulfil.
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 YOU’LL DO:

• Strategy Planning – The role will actively contribute to strategic decision for development assets and marketed products of any innovative medicines in the ADVANZ Innovative Medicines portfolio – this will involve (but not restricted to):
• In collaboration with the medical and clinical operation team/ external regulatory consultants, assess adequacy of the non-clinical and 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 development 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 actively in development of any future development plans working closely with medical office and regulatory new products team to support the MAA – (specifically – regulatory strategic considerations like non-clinical and clinical data package required to support MAA, clinical study protocol –clinical study report Post Approval Safety/Efficacy Study including observational studies PIP under Article 7 or any other specific obligations for Marketing Authorisation Application
• Pre-submission HA Interaction – This role will be driving all HA interactions specially for any clinical development led interactions. The role will be supported by CMC / regulatory experts from New products team as and when required for HA interactions on those elements, however this role will be the primary point of contact and will coordinate all activities leading to SAM. This role will take a supportive role to the Strategic Project- New Product team from the stages of pre-submission meeting onwards, where Strategic Project team will become the HA point of contact and will manage the regulatory procedure.
• 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 and any responses to questions on Module 4/5 during review. 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 – Strategic Project Lead to finalise rest of sections of MAA. The role will also be responsible for review of product label (SmPC).
• 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.
• Post Approval: This role will continue to remain as the global product lead and will be responsible to work collaboratively to define various post approval scenarios/strategies which may include (but not limiting to) labelling strategy, PIP strategy under Article 8, expansion of product to newer markets. This role will be supported by LCM team to help manage regulatory procedure during this duration. The role will handover the accountability to LCM team only once all post approval commitments are fulfilled and no further label changes are anticipated.
• Other responsibilities (not limited to)
• Work very closely with heads of– Regulatory Affairs New Products and Life cycle Management 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 Strategic Project leads 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.
• 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.