Regulatory Affairs Manager Job

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

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- 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
- 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)

WHAT YOU'LL BE DOING:

- Prepare and deliver regulatory operational plans for allocated projects/products.
- 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.
- 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, 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:

- 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
- Excellent written and verbal communication skills
- Scientific knowledge sufficient to understand all aspects of regulatory issues

OPPORTUNITY IS CALLING, APPLY NOW!

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WNECLIN

Ref: AZNJP

SFSF: LS