Regulatory Affairs Manager (1231)
Regulatory Affairs Manager - ONE YEAR CONBTRACT POSITION (with possible extension)
Description- Prepare and deliver regulatory operational plans for allocated projects/products. Contribute to solutions to regulatory issues. Project manage quality regulatory submissions to agreed project targets. Provide operational regulatory input and guidance in cross-functional teams. Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.
Accountabilities/
Responsibilities:
o Acting as a Project Manager for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets:
o Successful regulatory approvals
o Optimum market access
o Maintenance of product licenses
o Regulatory compliance
o Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
o Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
o Support Regulatory Affairs Director (RAD) or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
o Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program.
o Delivers project assignments supporting the business, e.g., representation on global cross-functional task forces or regulatory workstreams.
o Ensure that appropriate, up-to-date records are maintained for compliance.
Minimum Requirements -Education and Experience
o University Degree in Science or related discipline
o Cross-functional project team experience
o Project Management experience
o minumum 4 or more years relevant regulatory experience or Biopharmaceutical Industry
experience
o Excellent written and verbal communication skills
o Thorough knowledge of the drug development process
o Scientific knowledge sufficient to understand all aspects of regulatory issuesEstimated Salary: $20 to $28 per hour based on qualifications.
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