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Opportunity for Senior Global Maintenance Regulatory Manager in Novartis | M.Pharm, M.Sc, Ph.D-Life Sciences

 

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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: (Senior) Global Maintenance Regulatory Manager

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

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Candidate Profile:
Ideal Background (State the preferred education and experience level) Education (minimum/ desirable): University Degree or PhD in Life Sciences, Pharmacy or Medicine Languages: Fluency in English as business language, additional European languages advantageous Experience/Professional requirement:
• Minimum 2-3 years experience in EU (or global) regulatory affairs, related areas of the pharmaceutical Industry or Health Authorities
• (Senior): Extensive experience (5-10 years) in EU (or global) regulatory affairs
• Good interpersonal and communication skills, ability to work effectively in a matrix environment

Additional Information:
Experience: 2-3 years
Location:
Hyderabad
Education: M.Pharm, M.Sc, Ph.D-Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
Human Resources
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
221711BR
End Date: 30th September, 2017

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