29/03 Consultant R
Senior Consultant at Freelancing

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Global Regulatory Leader - Seasonal Influenza - Healthcare/Pharma (10-16 yrs)

Rockville/Maryland Job Code: 2906

Global Regulatory Leader - Seasonal Influenza

Basic Qualifications :

- Advanced Scientific Degree

- General Science or Life Science Degree

- 8+ years significant experience in managing regulatory projects, or appropriate experience.

Preferred Qualifications :

- Ph.D.

- Pharmacy, Chemistry, Biology or Medicine

- Direct experience in the development of medicinal products and obtaining licenses in different geographical areas.

- Strategic thinker - ability to connect different elements together.

- Evidence of proactive leadership to identify issues and mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence

- Good influencing and presentation skills to ensure that COMPANY Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams, with other COMPANY divisions or during meetings with regulatory agencies.

- Culturally aware.

- Proven ability to manage individuals (including indirectly) and teams in the delivery of outputs in a timely manner

- Ability to resolve problems through resourceful use of information and contacts.

- Enterprise thinking - needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.

- Credible externally as the - face of COMPANY-

- Recognized excellent communication skills, both oral and written.

- Fluent in English, with excellent writing skills.

- Able to develop Company's regulatory positioning, and write strategic documents targeting internal or external key audiences

Details :

- Manage regulatory activities in order to obtain Marketing Authorizations for commercial products as rapidly as possible, obtaining the best possible label, and to maintain these authorizations.

- Determine from a strategic and scientific perspective the content of technical, pre-clinical and clinical sections of product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Pediatric Investigational Plans) to ensure that these documents meet high scientific standards and regulatory requirements.

- For cross-product sections or stand-alone documents work with the function to ensure content is aligned with targeted overall profile of the product.

- Provide input into all development stages of the products within a given product portfolio. Contribute, from an RA perspective, to the establishment of the product development strategy and its execution in order to ensure a complete and rapid development of the asset.

- Provide robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.

The role has the following responsibilities :

- Manage a team of regulatory professionals on strategy development and implementation in support of licensing and life cycle management activities.

- Act as, or manage, the single point of Regulatory contact for Project Teams (PTs) and/or Vaccine Leadership Teams (VLTs), as appropriate, plus other internal project related teams (e.g. LTT, SRT etc.) and possibly teams with the rest of COMPANY corporation;

- Participate to project discussions and provide strategic, scientific and RA input.

- Develop the asset specific regulatory strategy on a global scale

- Global Regulatory Plan (GRP) ownership and accountability;

- Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities

- Ensure that the content of product/portfolio specific regulatory documents is in line with COMPANY Vaccines (or corporate) objectives

- Ensure high quality of product/portfolio specific regulatory documents submitted to Authorities and ensures that those documents meet regulatory requirements.

- Provide input to Vaccines Development Plans in order to optimize the label and secure proper alignment of technical, clinical and non-clinical aspects and the use of appropriate regulatory procedures to secure the optimum submission strategy;

- Communicate relevant asset specific information to enable colleagues (eg. VDL and LOC) to prepare the external environment in a timely fashion;

- Key driver for the lifecycle of the asset;

- Point of contact for Regulatory Agencies for asset(s)

- Assure efficient interactions with the regulatory authorities to achieve on-time approvals of COMPANY Vaccines submissions for the asset(s)

- Coordinate early interactions with key authorities to obtain input on clinical, technical and/or non-clinical development strategy and, as appropriate, on the optimal regulatory pathway to follow to secure registration and/or approval of regulatory submissions for the given asset(s)

- Ensure in collaboration with the relevant RA functions, as appropriate, the resources to ensure execute the agreed RA plan.

- Lead the regulatory team responsible for execution of the regulatory strategy for a project/product.

- Develop and motivate collaborators so to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.

- Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).

- Ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.

Company Details :

At COMPANY, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

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