Global Regulatory Affairs Senior Manager APAC

Location: Northern CA
Contact: Jackie Bandish,
jackie@bandishgroup.com

THE ROLE:

Global Regulatory Affairs Senior Manager | Innovative Growing Company

DESCRIPTION:

We are seeking a management level individual who wants to advance their career to the next level. Our growing client is extremely innovative and has an expanding and diverse portfolio in infectious disease and oncology.

One will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals.

This individual must be able to work in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment.

The APAC region includes greater China, S.E. Asia, Greater India, S. Korea and surrounding countries.

ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:

  • One must have IVD or Medical Device experience.

  • Must have previous managerial experience with at least 2-3 direct reports.

  • One will assist with ROW submissions.

  • Travel time is expected to be around 20%.

HIGHLIGHTS OF RESPONSIBILITIES:

  • Responsible for regulatory project timelines and management of global regulatory submissions.

  • Lead regulatory activities including planning and reviewing of regulatory submissions.

  • Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.

  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives.

  • Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements.

  • Interact with global regulatory leaders and peers to expedite approval of pending registrations.

  • Interact with departments to generate protocols and reports that require in-country testing data for registration purposes.

  • Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.

  • Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed.

DESIRED SKILLS AND QUALIFICATIONS:

  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level.

  • A minimum of 5-6 years of experience in regulatory/Quality or related departments within an IVD or medical device industry.

  • A minimum of 3-5 years managerial experience with 2-3 direct reports.

CONTACT:

Jackie Bandish, Head of Life Sciences Recruiting and Operations
Phone: 267-483-5233 ext. 104
Email: jackie@bandishgroup.com

The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976
www.bandishgroup.com