Regulatory Affairs Manager CMC

  • Location

    Germany

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    benefits package

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    PHARM-DEB_1582188435

  • Published:

    8 months ago

  • Expiry date:

    2020-03-21

  • Startdate:

    ASAP

This role will provide leadership and oversight to support the development of all the products in the company's portfolio across phases of development, therapeutic areas and moiety. This role will involve working with the global teams and management of staff.
The ideal candidate for this leadership role will have a strong understanding of the CMC regulatory requirements across regions, phases of development and indications for biologic, synthetic, and/or biosimilar products. This role will also require coordination of resources and tasks across the company sites.

Responsibilities
*You will collaborate with other leadership to ensure alignment across the teams.
*You will lead process improvements, documenting CMC processes and ensuring appropriate consultation with all stakeholders.
*You will provide expertise and guidance to interdepartmental and cross-functional teams.
*You will supervise assigned team members with respect to management, training, resource planning and recruitment across the Global and Regional CMC organizations.
*You will support CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals and responses to agency request for Information across all regions.

Your Qualifications

*Degree educated with strong experience within regulatory or compliance environment
*CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products
*Preparation of global CMC submissions across all phases of development
*In-depth knowledge of global CMC requirements, including country specific documents for regional submissions
*Experience managing and leading regulatory strategies for submissions including but not limited to IND/CTAs, Marketing Application/Authorization, Annual Reports, post approval supplements/variations, etc.
*Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
*Ability to work in a fast-paced environment while retaining a high attention to detail and quality
*Strong oral and written communication skills
*Strong interpersonal, collaborative, problem solving and conflict resolution skills
*Ability to develop solutions to technical and organizational issues to improve performance and productivity

Preferred Qualifications

*Degree in life sciences, biochemistry, or chemistry
*Experience in leading Global regulatory CMC submissions and an understanding of global requirements and ICH guidance
*Experience with manufacturing, process development, quality control, or quality assurance
*Experience with training and/or managing staff