Our Client

Our client is a multinational Pharmaceutical company with North American head office in New York

 

 

Position Description

• Provide a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, developing innovative solutions to minimize costs, yet deliver on company strategies and proactively influencing the global regulatory strategy.

• Contribute to company Global Regulatory Strategy through participation on the Global Regulatory Affairs Leadership Team (GRALT) and SMRT.

• Work closely with the Global Head,l Regulatory Affairs to maintain an effective Global Regulatory Affairs organization.

• Provide strategic leadership of Seqirus product development and registration projects to meet the global business objectives for the region.

• Actively contribute to the global regulatory community through designated projects. Build and maintain relationships with Global Regulatory Affairs at different sites across the Seqirus organisation.

• Ensure and monitor local registration activities including the development of processes to ensure efficient and timely registration of new products and maintenance of existing products.

• Ensure strategic input from the Americas Region is provided at GRAST meetings and key information/learnings from GRAST meetings shared back

• Ensure the timely and efficient identification of regulatory risks associated with the products and issues relating to emerging regulatory environment changes and escalation to Global Head of RA and as appropriate to senior management.

• Ensure high quality, right first time submissions in line with corporate objectives; managing major and minor applications to meet business objectives and timelines with competitive outcomes in the region.

• Oversee the development of strong working/partnering relationships with key agencies in the region, usually working through the local country regulatory managers/consultants (i.e. FDA, Health Canada(BGTD),LATAM (ANVISA etc))

• Full compliance with all government regulations and corporate policies including oversight of corrective actions for which the regional regulatory team is accountable

• Single point of contact for integration of Regional, Country and Seqirus Business Unit regulatory activities. A recognized regional partner for other regional focused business activities and initiatives

• In collaboration with Healthcare Policy and External Affairs, advocate for Seqirus by building strong relationships with key external stakeholders (e.g. trade associations and professional bodies). Work externally to influence the regulatory environment in line with Seqirus and where appropriate CSL policy priorities

• Direct working relationships with the regional/global clinical and technical R&D associated assigned with the region

• Direct the growth and professional development of the regional Regulatory Strategy team members, including succession planning for critical roles with the regional and global regulatory leadership

• Regional Heads Coordinator: establishes and leads a regional forum consisting of all GRA Region Heads to align on direction and priority for GRA policy activities.

• GRA External Relations & Policy Coordinator: sets direction for GRA policy activities and coordinates trade association engagement and direction with Healthcare Policy and External Affairs, drives global regulatory advocacy activities for Seqirus by building relationships with key external stakeholders (e.g. trade associations and professional bodies) in collaboration with other Region Heads and the Global Head of RA

 

 

Qualifications

• BS/BA degree and at least 2 years of pharmaceutical industry experience.

• Preferred experience in a related aspect of drug development Phase 1 through 4.

• Basic knowledge of relationship of scientific data and regulatory requirements.

• Demonstrates acceptable skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

• Demonstrates developing skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

• Works well with other

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We thank you in advance for your application however only those selected for an interview will be contacted.