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Head of Regulatory Affairs, UK/I and Emerging Markets - London December 3, 2008

Senior Director/Director Regulatory Affairs Europe - Belgium September 12, 2008

Regional Regulatory Therapeutic Head - Switzerland July 17, 2008

Global Regulatory Affairs Director - Switzerland June 18, 2008

Global Regulatory Affairs Director - Switzerland

Our client is a leading pharmaceutical research and development company who is looking to recruit a candidate of outstanding experience and ability to fullfil the significant global responsibilities detailed in the following description. With some exceptional projects in this therapeutic group we are looking for a candidate with significant experience in the regional/global development of pharmaceutical and/or biologic products. This critical experience of product development and life-cycle management must be accompanied with strong leadership qualities and the personal characteristics to work effectively in a complex global setting.

Global drug regulatory affairs leader of a global program/brand team consisting of at least one Heavyweight/Key project in development or a brand with major ongoing development activities, requiring complex regulatory strategies. Functions as a core member of the Global Program Team (GPT) or Global Brand Team (GBT) to define the global regulatory strategy for the development, submission, approval and life cycle management of the project(s) and/or brand(s) in the major and emerging markets. Leader of global regulatory team for the program.

Major Accountabilities

Regulatory Strategy:

Responsible for Heavyweight/Key project (potential to develop into a major product for company) or complex group of programs.

Development of strategic approach and global regulatory input to achieve optimal development and life cycle management plans

Responsible for development and implementation of the Regulatory Functional Plan

Provide global regulatory direction and evaluate regulatory risks/gaps and trade-offs for the overall development plan; develop contingency plans for identified risks

Ensure that execution of regional regulatory strategies are aligned with global strategy

Responsible for obtaining timely consultation with company regulatory advisory boards on regulatory strategy

Lead interactions with regulatory consultants for strategic input and challenge

Accountable for developing regulatory readiness/advocacy strategy and driving process

Represents DRA on the GPT or GBT

Health Authority Interactions:

Develop global regulatory strategy and plans for Health Authority (HA) interactions with GPT/GBT

Provide leadership by supporting the RBRM in his/her direct interactions with HAs

Provide strategic input to GPT/GBT and DRA subteam on key HA documents

Submissions and Approvals:

Lead the global submission planning process

Derive regulatory strategy for submission; determine which submission procedures to utilize; provide strategic review of dossier summaries, expert statements, and risk management plans

Identify issues, gaps, options and trade-offs for development plan leading to an optimal and timely submission and approval

Prescribing Information:

Accountable for developing the Development Core Data Sheet (DCDS) with the GPT, consistent with development data and commercial objectives of the Target Product Profile (TPP)

Responsible for implementation of CDS and TPP into labels in major regions (US, EU, Japan and Emerging Growth Markets)

Identification of potential label issues/gaps and develop global regulatory label negotiation strategy with contingency planning

Compliance:

Accountable for ensuring regulatory compliance for brand

Responsibility for DRA review of global promotional materials

Promotional Review:

Review of promotional materials and press releases for NP4

Managerial

Management of direct/indirect reports; leads DRA subteam consisting of RBRM’s in both EU and US, together with DRA from other regions, and other DRA line functions.

Advanced leadership skills. Provides mentoring and coaching for members of DRA subteam. Serves as role model and embraces company Values and Behaviors. Leads by example.

Key Performance Indicators

Successful global regulatory strategy is defined for timely submission and approvals with commercially attractive labels

Identification of significant issues and options for addressing them in the RFP

Regulatory strategy presented to company boards

Successful negotiations with HA interactions to achieve business objectives

Fulfil regulatory responsibilities to the IPT to achieve business objectives

Job Dimensions

Number of associates: Direct reports: 1-2

Indirect reports: 6-8

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

Responsible for projections of internal FTEs and external costs for brand(s) to be provided to DRA Planning and Administration and to GPD/Brand Leader

Impact on the organisation:

Develop strategic plans and regulatory risk assessments and create innovative regulatory solutions. Achieve timely submissions/approvals and secure adherence of the company to regulatory requirements. Ability to lead and manage a team of regulatory professionals at a high performance level.

Ideal Background (State the preferred education and experience level)

Education: PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience. Demonstrated experience of successfully leading a medium/high impact regulatory brand/project or projects.

Languages: Fluency in English (oral and written)

Experience:

8-10 years of involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in most or all of the following areas:

Innovation in regulatory strategy.

Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.

Involvement in a CTD/MAA submission and approval.

Leadership role in HA negotiations in multiple regions

Proven success in global drug regulatory submission and commercialization.

Proven ability to analyze and interpret efficacy and safety data.

Regulatory operational expertise.

5 or more years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.

5 or more years people management experience required; this may include management in a matrix environment.

Global people management experience desirable.

Strong management, interpersonal, communication, negotiation and problem solving skills.

Proven ability to contribute to GPT/GPT strategies in areas outside of DRA.

Considerable organizational awareness (e.g., interrelationship of departments, business priorities), including significant experience working crossfunctionally and in global teams.

If you would be interested in knowing more about this position then please call us directly on telephone +44 (0)207 370 6451 or email at info@liftstream.com.

Liftstream has completed this search but has a commenced a new identical search as of November 21st 2008. We invite additional candidates to apply until further notice.


Organisation Relationships Innovation Growth Jobs Candidate Introduction Career Management Featured Job Featured Cluster Featured Client Global Network Environment Jobs	Featured Jobs Head of Regulatory Affairs, UK/I and Emerging Markets - London December 3, 2008 Senior Director/Director Regulatory Affairs Europe - Belgium September 12, 2008 Regional Regulatory Therapeutic Head - Switzerland July 17, 2008 Global Regulatory Affairs Director - Switzerland June 18, 2008 Global Regulatory Affairs Director - Switzerland Our client is a leading pharmaceutical research and development company who is looking to recruit a candidate of outstanding experience and ability to fullfil the significant global responsibilities detailed in the following description. With some exceptional projects in this therapeutic group we are looking for a candidate with significant experience in the regional/global development of pharmaceutical and/or biologic products. This critical experience of product development and life-cycle management must be accompanied with strong leadership qualities and the personal characteristics to work effectively in a complex global setting. Global drug regulatory affairs leader of a global program/brand team consisting of at least one Heavyweight/Key project in development or a brand with major ongoing development activities, requiring complex regulatory strategies. Functions as a core member of the Global Program Team (GPT) or Global Brand Team (GBT) to define the global regulatory strategy for the development, submission, approval and life cycle management of the project(s) and/or brand(s) in the major and emerging markets. Leader of global regulatory team for the program. Major Accountabilities Regulatory Strategy: Responsible for Heavyweight/Key project (potential to develop into a major product for company) or complex group of programs. Development of strategic approach and global regulatory input to achieve optimal development and life cycle management plans Responsible for development and implementation of the Regulatory Functional Plan Provide global regulatory direction and evaluate regulatory risks/gaps and trade-offs for the overall development plan; develop contingency plans for identified risks Ensure that execution of regional regulatory strategies are aligned with global strategy Responsible for obtaining timely consultation with company regulatory advisory boards on regulatory strategy Lead interactions with regulatory consultants for strategic input and challenge Accountable for developing regulatory readiness/advocacy strategy and driving process Represents DRA on the GPT or GBT Health Authority Interactions: Develop global regulatory strategy and plans for Health Authority (HA) interactions with GPT/GBT Provide leadership by supporting the RBRM in his/her direct interactions with HAs Provide strategic input to GPT/GBT and DRA subteam on key HA documents Submissions and Approvals: Lead the global submission planning process Derive regulatory strategy for submission; determine which submission procedures to utilize; provide strategic review of dossier summaries, expert statements, and risk management plans Identify issues, gaps, options and trade-offs for development plan leading to an optimal and timely submission and approval Prescribing Information: Accountable for developing the Development Core Data Sheet (DCDS) with the GPT, consistent with development data and commercial objectives of the Target Product Profile (TPP) Responsible for implementation of CDS and TPP into labels in major regions (US, EU, Japan and Emerging Growth Markets) Identification of potential label issues/gaps and develop global regulatory label negotiation strategy with contingency planning Compliance: Accountable for ensuring regulatory compliance for brand Responsibility for DRA review of global promotional materials Promotional Review: Review of promotional materials and press releases for NP4 Managerial Management of direct/indirect reports; leads DRA subteam consisting of RBRM’s in both EU and US, together with DRA from other regions, and other DRA line functions. Advanced leadership skills. Provides mentoring and coaching for members of DRA subteam. Serves as role model and embraces company Values and Behaviors. Leads by example. Key Performance Indicators Successful global regulatory strategy is defined for timely submission and approvals with commercially attractive labels Identification of significant issues and options for addressing them in the RFP Regulatory strategy presented to company boards Successful negotiations with HA interactions to achieve business objectives Fulfil regulatory responsibilities to the IPT to achieve business objectives Job Dimensions Number of associates: Direct reports: 1-2 Indirect reports: 6-8 Financial responsibility: (Budget, Cost, Sales, etc.) Responsible for projections of internal FTEs and external costs for brand(s) to be provided to DRA Planning and Administration and to GPD/Brand Leader Impact on the organisation: Develop strategic plans and regulatory risk assessments and create innovative regulatory solutions. Achieve timely submissions/approvals and secure adherence of the company to regulatory requirements. Ability to lead and manage a team of regulatory professionals at a high performance level. Ideal Background (State the preferred education and experience level) Education: PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience. Demonstrated experience of successfully leading a medium/high impact regulatory brand/project or projects. Languages: Fluency in English (oral and written) Experience: 8-10 years of involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in most or all of the following areas: Innovation in regulatory strategy. Prior history with post-marketing/brand optimization strategies and commercial awareness preferred. Involvement in a CTD/MAA submission and approval. Leadership role in HA negotiations in multiple regions Proven success in global drug regulatory submission and commercialization. Proven ability to analyze and interpret efficacy and safety data. Regulatory operational expertise. 5 or more years of demonstrated leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry. 5 or more years people management experience required; this may include management in a matrix environment. Global people management experience desirable. Strong management, interpersonal, communication, negotiation and problem solving skills. Proven ability to contribute to GPT/GPT strategies in areas outside of DRA. Considerable organizational awareness (e.g., interrelationship of departments, business priorities), including significant experience working crossfunctionally and in global teams. If you would be interested in knowing more about this position then please call us directly on telephone +44 (0)207 370 6451 or email at info@liftstream.com. Liftstream has completed this search but has a commenced a new identical search as of November 21st 2008. We invite additional candidates to apply until further notice.
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