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KLINEXA is a scientifically focused contract research organization that provides pharmaceutical, biotechnology and medical device companies with a full range of services.

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Regulatory Affairs Manager

Regulatory Affairs Manager multiple positions  ** Please make sure that all candidates have a min of 2 years of industry (pharma or CRO) experience doing submissions within reg affairs

Gaithersburg, MD

6-36 months

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.

• 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

• Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
• Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
• Support Regulatory Affairs Director (RAD) or assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program.
• Delivers project assignments supporting the business, e.g., representation on global cross-functional task forces or regulatory workstreams.
• Ensure that appropriate, up-to-date records are maintained for compliance.

Minimum Requirements –Education and Experience

The candidate will be expected to be hands-on in planning and executing on product specific global regulatory strategy plans, which include and are not limited to timelines and submissions as well as providing regulatory guidance.
• University Degree in Science or related discipline
• Cross-functional project team experience
• Project Management experience
• Minimum 2 or more year relevant regulatory experience (relevant regulatory experience includes managing or coordinating submission related activities associated with INDs, CTAs, NDAs, BLAs, or MAAs preferably clinical or preclinical related submissions or license renewals)
• Minimum 4 or more years pharmaceutical or biopharmaceutical Industry experience
• Excellent written and verbal communication skills
• Thorough knowledge of the drug development process (preclinical development ? Pre-IND/Pre-CTA ? IND/CTA ? clinical development [Phase 1, 2, 3] ? registration [NDA/BLA/MAA] ? post-marketing [license renewals and sNDA for new indications] ? life-cycle management)
• Scientific knowledge sufficient to understand all aspects of regulatory issues


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