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Manager, Regulatory Affairs-CMC

Company: BioDuro-Sundia
Location: Irvine
Posted on: January 15, 2022

Job Description:

Job Title: Manager, Regulatory Affairs - CMC

Department: Regulatory Affairs

Reporting To: VP of Quality & Compliance

Classification: Exempt, Full-time

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in San Diego, CA. Our 10 facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical, clinical, and commercial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

Management of regulatory activities for all projects assigned to the CMC group. Ensure regulatory conformance for commercial products through effective change management and collaboration with BioDuro-Sundia Clients. Maintain a high-level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy. Manage group activities and provide regulatory strategy for proper life-cycle management. Provide regulatory support for due diligence activities associated with the assessment of business opportunities, phase appropriate development of products, and the submission of requisite reports and filings to health authorities.

Essential Functions And Responsibilities

  • Management of all regulatory activities for development and commercial projects assigned to the group.
  • Act or assign a regulatory representative for each project team.
  • Oversee and collaborate with Clients regarding the development and implementation of a regulatory submission strategy.
  • Manage the planning, preparation and technical review of regulatory submissions and reports, and ensure submissions are completed to meet required/established timelines.
  • Collaborate on the development and/or optimization of product development strategy to be consistent with regulatory requirements.
  • Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions.
  • Will be a hands-on manager, and can cover for and execute work themselves if staff members need aid or are on temporary leave.
  • Maintain a high-level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.
  • Provide regulatory guidance and strategy for life-cycle management planning and development for commercial products.
  • Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes.
  • Ensure regulatory conformance for commercial products through effective change management.
  • Manage budget associated with group activities including submission fees (ex-US), business travel and training.
  • Provide regulatory support for due diligence activities associated with the assessment of business opportunities.

    Requirements
    • Degree in a scientific/technical discipline (Ph.D., MS Science or PharmD.) with a minimum 5 years' pharmaceutical drug development experience and hands-on regulatory experience.
    • Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.
    • Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals.
    • Basic computer skills (MS Office, Excel and Adobe Acrobat).
    • Experience supporting and conducting due diligence activities.
    • Strong knowledge of regulations/guidelines governing pharmaceutical development.
    • Familiarity/understanding of FDA regulatory processes (experience with ex-US regulatory authorities/processes is desired).
    • Ability to communicate clearly and concisely with senior management, Clients, and regulatory authorities.
    • Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.
    • Ability to effectively delegate tasks and hold others accountable.

      Preferred Qualifications
      • Strong technical writing skills
      • Familiarity and experience with Quality Management Systems
      • Familiarity and experience with ICH Guidelines
      • Familiarity and experience with the CRDMO business model

        Benefits

        BioDuro-Sundia employment provides the opportunity to work in beautiful Irvine, California. We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

        EOE and Accommodation

        We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@BioDuro-Sundia.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Keywords: BioDuro-Sundia, Irvine , Manager, Regulatory Affairs-CMC, Executive , Irvine, California

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