Regulatory Affairs Manager Job

REGULATORY AFFAIRS MANAGER needed for a CONTRACT opportunity with Yoh's client located in Wilmington, DE.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Project Management
- Regulatory Affairs

WHAT YOU'LL BE DOING:

- 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 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, eg, representation on global cross-functional task forces or regulatory workstreams.
- Ensure that appropriate, up-to-date records are maintained for compliance.

WHAT YOU NEED TO BRING TO THE TABLE:

- University Degree in Science or related discipline
- Cross-functional project team experience
- Project Management experience
- Relevant regulatory experience or experience elsewhere in Pharmaceutical Industry eg Marketing Company, Health Authority, R&D or Operations
- Excellent written and verbal communication skills
- Thorough knowledge of the drug development process
- Scientific knowledge sufficient to understand all aspects of regulatory issues
- Knowledge of pharmaceutical Business and processes
- Two years regulatory experience of working in at least one area of regulatory affairs
- Global team experience

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. If you are an individual with a disability and you require an accommodation in the application process, please email.

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