The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements.
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 Specialist Regulatory Affairs LCM Strategic Growth Products.
Main purpose of the job
is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. - Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities.
- Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as we'll become the single point of contact for the organization.
- This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies.
This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following:
- Renewal Application and Annual Maintenance
- Variation Application
- Notification of Change in Marketing Status, sunset clause exemptions where applicable
- Notification of drug shortages
- Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products.
- PIP Modifications, PIP compliance and associated label update
- Orphan Designation Maintenance (where applicable)
- Updation of NBO technical package (where applicable)
- This role will be assigned specific molecules, Primarily Innovative Medicines (but may as we'll extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc for their assigned molecules.
- This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products.
- This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy.
- This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis.
- This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products.
- While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, howe'ver, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team.
- Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives.
- Act as process owner for some regulatory procedures as and when delegated.
- Support line managers for readiness of any health authority inspection as and when delegated.
- Ensure timely completion of assigned Deviation and CAPAs.
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: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy.
Knowledge, Skills & Experience:
Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently we'll versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.
