Regulatory Affairs Manager Job

SENIOR REGULATORY AFFAIRS MANAGER needed for a CONTRACT opportunity with Yoh's client located in Gaithersburg, MD.

WHAT YOU'LL BE DOING:

- Prepare, agree and execute regulatory operational plans for allocated projects/products.
- Contribute to regulatory strategies and provide solutions to regulatory issues.
- Project manage quality regulatory submissions to agreed project targets.
- Provide operational and/or strategic regulatory input and guidance in cross-functional teams.
- Represent the RAD when appropriate.
- Work flexibly within and across the regions and Therapeutic Areas to provide broad operational support to ensure the delivery of product team and business objectives.
- Support the RAD to lead the delivery of timely approvals and advantageous product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and local market regulations.
- Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
- Liaise proactively with the functions and lead or participate as a member of cross-functional delivery teams for complex submissions, providing expert regulatory advice.
- Identify potential complex regulatory risks to the operational plans, and propose options to mitigate risks.
- Lead and 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.
- Prepare and maintain a competitive Core Data Sheet and related core texts in agreement with the RAD.
- Serve as the delegate, where appropriate, for the RAD.
- Maintain awareness of competitor's activities and share potential impact these activities may have on the product development program.
- Provide coaching, mentoring and training within the RAM skill group.
- Delivers project assignments supporting the business, eg, representation or leadership on global cross-functional task forces.
- Ensure that appropriate, up-to-date records are maintained for compliance.

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum Requirements
-Education and Experience
- Bachelors in Science or related discipline with five (5) year experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry (BioPharma or CRO), or experience at a health authority (FDA or MHRA or EMA or equivalent)
- PharmD with two (2) years of experience (as noted above)
- Leadership skills, including proven leadership of cross-functional project teams experience
- Excellent written and verbal communication skills
- Thorough knowledge of the drug development process
- Thorough scientific knowledge sufficient to understand all aspects of regulatory issues

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

MONJOBJ2WMIDATL

Ref:

SFSF: LS