VACANCY FOR THE POST OF GLOBAL MAINTENANCE REGULATORY MANAGER AT NOVARTIS, HYDERABAD

Job ID                                     221711BR

Position Title                          (Senior) Global Maintenance Regulatory Manager

Division                                  Global Drug Development

Business Unit                         REG AFFAIRS GDD

Country                                  India

Work Location                      Hyderabad

Company/Legal Entity         India Novartis Healthcare Private Limited

Functional Area                     Human Resources

Job Type                                 Full Time

Employment Type                 Regular

Sourcing Statement   You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.

Job Description   Job Purpose (State the overall objective of the role)
The Global Maintenance Regulatory Manager (GMRM) is responsible for maintaining the product licences in the European Union countries for assigned  Novartis Pharma registered products across all Business Units and Business Franchises. 

Additionally is responsible for the operation execution of specific regulatory deliverables (see below) relating to world-wide maintenance, upkeep and lifecycle management of assigned Established Medicines global brands without a formal global brand team (GBT) on a continual or ad-hoc basis as may be required. 

Major Accountabilities (Describe the main results of the role to be achieved)
EU Regulatory Maintenance activities: 

1. Lead and coordinate timely and high quality preparation of all necessary supporting documentation by internal or external experts for EU license renewals, EU variations (except CMC-related variations), PSUR submissions for assigned Novartis Pharma registered products approved via the: 

Ø Centralized Procedure (CP), 

Ø Mutual Recognition Procedure/Decentralized Procedure (MRP/DCP)
with the support of the respective Reference Member State (RMS) CPO, 

Ø National Procedure (renewals only - provide documentation as required
by the PONERC strategy). 

2. Interact with the EU Health Authorities to solve regulatory issues related to assigned Novartis Pharma registered products, as appropriate. Lead the HA Response Team through the regulatory maintenance processes. Represent DRA in negotiations with HA in EU in liaison with DRA CPOs or Novartis Europharm. 

3. Manage the interaction with DRA colleagues in CPOs and with Novartis agents where no CPO exists (e.g. Cyprus) for regulatory maintenance activities. 

4. Organise and lead the PL Readability Testing for assigned development and marketed products as appropriate. 

5. Integrate regulatory maintenance strategy into other DRA or product development activities through participation in GPT/GBT DRA Sub-Teams. 

6. Support EU referral procedures to ensure a smooth progression of the procedure by providing the BF/BU manager with source documents where needed to achieve the best possible labelling harmonization across EU. 

7. (Senior) Lead Urgent Safety Restrictions (USR) including the preparation of internal and external communication documents to the EU HAs involving multiple countries. 

Regulatory activities related to assigned Established Medicines global brands
without formal GBTs: 

1. Provide DRA input and collaboration with relevant GLFs (Global Marketing, BD&L, DRA-GL, DRA-AGL, Reg–CMC, CD&MA, DS&E) in creation of regulatory strategies and action plans to maximize the value of assigned. Established Medicine brands world-wide in line with commercial goals and regulatory commitments. 

2. Provide prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. HAs, CPOs) relating to assigned brands. 

3. Provide DRA input and collaborate with relevant GLFs, in planning and execution of agreed actions relating to the thorough and efficient management of regulatory procedures across EU, specifically EU referrals and art 45 procedures for assigned EM products. 

4. Provide DRA input for pruning, in- and out-licensing initiatives for assigned Established Medicines, world-wide. 

5. Collaborate with EMBF Global Marketing and relevant GLFs in creating strategies and action plans to ensure the maintenance of product licenses for assigned EM brands, world-wide. 

6. Provide DRA support in the regulatory evaluation and implementation of all out-licensing activities performed for Novartis products 

Additional tasks relevant to Senior level: 

1. Special expertise and seniority in all the above listed activities. 

2. Training and coaching junior members. 

3. Represent Novartis in EU Industry Interest Groups and other external regulatory working parties (e.g. DIA, EFPIA) to influence emerging EU regulatory maintenance guidelines. 

4. Review and adapt Novartis processes to emerging EU regulatory maintenance regulations. 

Key Performance Indicators (Indicate how performance for this role will be measured) 

Ø Metrics for submissions, approvals and other regulatory deliverables according to the business objectives. 

Ø Quality and timely completion of regulatory documentation, for assigned products and for other assigned initiatives. 

Ø Quality and timely development of regulatory strategies for assigned products and efficient execution of the strategies. 

Ø Quality and effectiveness of relationships with Novartis GLFs and external partners. 

Ø Quality and effectiveness of relationships with CPOs and pertinent Health Authorities, related to assigned products brands. 

Job Dimensions (Indicate key facts and figures) 

Number of associates:

Ø Financial responsibility: (Budget, Cost, Sales, etc.) 

Ø Impact on EU sales and EMBF global sales of assigned marketed products 

Ø Impact on the organisation: Responsible for the regulatory maintenance of assigned 

Ø Novartis Pharma products in Europe and brand upkeep and optimization of Established Medicines brands (without formal GBTs) world wide. 

Ideal Background (State the preferred education and experience level) 

Education (minimum/desirable): 

Ø University Degree or PhD in Life Sciences, Pharmacy or Medicine 

Ø Languages: Fluency in English as business language, additional European languages advantageous 

Experience/Professional requirement: 

Ø Minimum 2-3 years experience in EU (or global) regulatory affairs, related areas of the pharmaceutical Industry or Health Authorities 

Ø (Senior): Extensive experience (5-10 years) in EU (or global) regulatory affairs 

Ø Good interpersonal and communication skills, ability to work effectively in a matrix environment

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