Senior Regulatory Affairs Scientist - Region US
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POST DATE 9/15/2016
END DATE 1/21/2017
JOB DESCRIPTIONJob Purpose:
To provide strategic leadership, direction, and vision for the Regulatory Product Teams.
* Formulate, lead and drive the regional regulatory Strategy for Seqirus manufactured products, or influenza products
* Preparation, compilation and submission of high quality applications including marketing authorization applications, variations, renewals and responses to regulatory agency reviewer questions.
* Maintain up to date product labelling for all Seqirus territories (PI, CMI, SmPC, PIL etc) including translation requirements and manage regional consultants
* Ensure dossiers meet content requirements for regions
* Actively contribute to the global Seqirus regulatory community through designated projects. Build and maintain relationships with Global Regulatory Affairs across the Seqirus company.
* Gather, analyse and monitor publicly available Regulatory information relevant to Seqirus products and/or specific region requirements/proposed changes and communicate the implications to RA, Regions Head, and Regions Product Teams ( Commercial, Medical Affairs, Safety/Pharmacovigilance) and Medical Affairs colleagues, and for Inlicensed Products to Inlicensing Partner Companies
* Lead and oversee the Regulatory activities, which include but are not limited to submissions planning, regional specific labelling, and other activities as assigned
* Work closely with the RA Regions Head to develop and maintain an effective Global Regulatory Affairs organization through continuous improvement initiatives that deliver business excellence.
* Manage the functional budget, resource plans and monitor progress to ensure strategic objectives of the Region are achieved
* Manage training and development of staff to maximise their skills and abilities and optimise outcomes for Seqirus
* Deputise for RA, Regions Head as required
* Represent Seqirus at meetings with Regulatory Agencies
* Manage the contractual arrangements with contractors and partners/agents for Seqirus products
* Maintain awareness of and expertise in TGA, ICH, FDA and EU guidelines relevant to role
* Oversee the development of strong working/partnering relationships with regional regulatory agencies in terms of new submissions initiatives by working through the local country regulatory managers/consultants (i.e. FDA, Health Canada, EMA, TGA). Represent Seqirus at meetings with Regulatory Agencies
* Manage the contractual arrangements with service contractors to ensure full compliance with all government regulations and corporate policies.
* Bachelor s degree in biological or health sciences, pharmacy or related field. Advanced degree preferred.
* At least 4 years of regulatory affairs experience required.
* Understanding of scientific principles relevant to the development of a pharmaceutical product;
* Understanding of the principles of GxP;
* Demonstrated ability to lead, influence and motivate a team (evidenced by managing direct reports or RA lead in a cross functional project team);
* Demonstrated ability to deal with rapid change
* Ability to establish credible relationships within Seqirus and externally.
* Demonstrable experience of effective delivery of objectives in a complex matrix environment
* Ability to lead, influence and motivate a team is desired;
* Ability to identify big picture and opportunities/major issues and link day to day tasks with long term goals;
* Effective verbal and written communication skills in a cross functional environment;
Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.