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Regulatory Affairs Manager Jobs

Thousand Oaks, California

<p>Company Overview:</p><p>Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them – with service that exceeds their expectations and a personal commitment to their success.</p><p></p><p>About CLIENT:</p><p>Our client, is an American multinational biopharmaceutical company, seeks an accomplished Regulatory Affairs Manager</p><p>*******************************************************************************************************************</p><p>Position: Regulatory Affairs Manager</p><p>Location: Thousand Oaks CA 91320</p><p>Duration: upto 6 months</p><p></p><p>PAY RATE: $60- $70/hr on W2 (depending on experience)</p><p></p><p>Relocation Expenses/ Assistance: NO</p><p></p><p>JOB DESCRIPTION:</p><p>This is an opportunity for a Manager position in Global Regulatory Affairs and Safety group.The purpose of this role is to achieve the desired labeling by developing and executing US regulatory strategies.Execution of the US regulatory strategy includes: Planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirementsEnsuring that client acquires and maintains all the licenses to support clinical trials for investigational and marketed products in the USEnsuring regulatory compliance; managing effective US regulatory agency interactionsProviding content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions); under general supervision, developing US regulatory strategies, regulatory risks and predictions of interactions with regulatory agenciesProviding regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)</p><p></p><p>TOP 3 MUST HAVE SKILL SETS:</p><p>Experience with making regulatory submissions (eg, INDs) and interacting with FDAStrong communication skills – both oral and writtenAbility to understand and communicate scientific/clinical information</p><p></p><p>DAY TO DAY RESPONSIBILITIES:</p><p>Perform regulatory research to obtain relevant histories, precedence and other information relevant to product advancement in the USUnder supervision evaluate and communicate impact of relevant US regulations, guidances, current regulatory environment and competitor labellingLead Health Authority Interactions; With general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignmentDocument and communicate details and outcomes of FDA interactions to GRT and relevant sr. management; Under general supervision, participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategyincludes contingency regulatory planning/risk assessment</p><p>****************************************************************************************************************</p><p>I’d love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction.</p><p></p><p>If you’re looking for rewarding employment and a company that puts its employees first, we’d like to work with you.</p><p></p><p>Sajag Bhardwaj</p><p>Recruiter</p><p>*******************************************************************************************************************</p><p>NOTE: Candidates that are offered a position are required to pass pre-employment drug and background screening.</p>

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