Regulatory Affairs Senior Manager (Device) Job

REGULATORY AFFAIRS SENIOR MANAGER (device) needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA.

THE BIG PICTURE:

- The RA Biosimilars Team is responsible for generation and implementation of the global regulatory strategies
- Development and implementation of regulatory plans for CTA, CTD and related agency submissions for biosimilar products.

WHAT YOU'LL BE DOING:

- Contribute to the development of, and lead the implementation of, regulatory strategies that result in the execution of regulatory plans for meeting information, INDs, and CTDs for biosimilar products for submission to global regulatory authorities.
- Ensure that Client acquires and maintains all the required approvals in order to support clinical trials for investigational products as well as approved products.
- Ensure timely compliance with all regulatory requirements to support the development and approval of biosimilar products.
- With minimal supervision, develop and manage regulatory submissions (eg clinical trial and marketing applications) for products within Client's biosimilars portfolio in compliance with global filing plans and local regulatory requirements.
- Lead development of regional regulatory documents and meetings in accordance with the biosimilars regulatory strategy
- Implement product-related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development
- Contribute to the development of regional product labels for biosimilars by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manage regional label negotiation activities
- Co-ordinates company responses to requests from regulatory authorities, (eg Response to Questions (RTQs)
- Communicate regulatory strategies as appropriate such that expectations are understood.
- Estimate the likelihood of regulatory success based on proposed strategies and discuss with the regulatory team and cross-function leads
- Ensure compliance with internal company requirements
- Represent the Biosimilars Regulatory Affairs Team to outside departments and product teams

WHAT YOU NEED TO BRING TO THE TABLE:

- Doctorate degree and two (2+) years of directly related experience OR
- Master's degree and six (6+) years of directly related experience OR
- Bachelor's degree and eight (8+) years of directly related experience OR
- Associate's degree and ten (10+) years of directly related experience OR
- High school diploma/GED and twelve (12+) years of directly related experience
- Degree in Life Sciences, Engineering or related field
- Seven (7+) years of related experience in the pharmaceutical/biotechnology or medical device industry
- Five (5+) years of experience in Regulatory Affairs
- Experience in the development of CTDs for biologics
- Understanding of the regional regulatory procedures for CTAs, marketing applications, post approval changes, extensions and renewals
- Understanding of drug development
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Experience in working with policies, procedures and SOPs
- Planning and organizational skills
- Excellent interpersonal skills - and ability to work in a team Matrix environment
- Strong oral and written communication skills
- Able to multi-task and operate in a fast-paced, dynamic environment
- Strong negotiating, leadership and problem solving skills
- Able to manage and execute activities to meet agreed upon timelines

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- International experience - preferred

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a DayJ2W: CLINICAL

MONJOB J2WSWSCI

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SFSF: LS