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Manager, Regulatory Affairs, Genomics Medicine

Company: Danaher Corporation
Location: Los Angeles
Posted on: May 28, 2023

Job Description:

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.Job Title: Manager, Regulatory Affairs, Genomics MedicineLocation: RemoteWe believe in designing a better, more sustainable workforce.We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.This position is eligible for a remote work arrangement in which you can work remotely from your home.Additional information about this remote work arrangement will be provided by your interview team.Explore the flexibility and challenge that working here can provide.The Manager, Regulatory Affairs, Genomics Medicine will lead, coordinate and execute regulatory activities related to the IDT cGMP/Q7 contract manufacturing business to support the regulated therapeutics industry on their customer journey from discovery, clinical trials and commercialization of customer products and further growth of the IDT Genomics Medicine RA function.Essential Functions:

  • Act as a core team member of the customer intake process and set up to provide guidance to customers and cross-functional teams on regulatory requirements specific to the project presented.
  • Plan, prepare, review and lead regulatory activities related to Drug Master Files (DMF), Chemistry, Manufacturing and Control (CMC) Modules and other required regulatory documentation associated with investigational new drug (IND), new drug application (NDA), and biologics applications (BLA) throughout the customer journey.
  • Maintain and update records related to the Site Master File, Annual Reports and Agency site registration activities.
  • Provide guidance to cross-functional quality and manufacturing teams regarding regulatory requirements associated with change requests, regulatory assessments and implementation.
  • Manage and align submission timelines and project deliverables to meet customer needs.
  • Develop and maintain current regulatory knowledge and advise management of significant developments.
  • Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.
  • Performs other duties as assigned. Education, Licensure, Certification, Registration
    • Bachelor's degree in pharmaceutical, health science or related technical field such as chemistry, biochemistry, biology, etc. Professional Experience:
      • Minimum 7 years of experience in regulatory role
      • Experience and knowledge in the preparation of DMF and CMC Modules related to INDs, NDA, and/or BLA.
      • Experience with submission formatting and CTD/eCTD.
      • Working knowledge of FDA and ICH regulatory requirements.
      • Knowledge/experience with regulatory requirements for other regions also desirable
      • Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle as it relates to intermediates and active pharmaceutical ingredients (API). Other Knowledge, Skills and Abilities
        • Proficient in Microsoft Suite.
        • Detail oriented with well developed organizational and analytical skills.
        • Excellent oral/written communication and presentation skills.
        • Ability to identify risk and escalate accordingly. What We Offer:
          • Shift Differentials (Extra Compensation for less traditional shifts)
          • Generous Paid Time Off Accruals
          • 16 Hours PAID Volunteer Time Off
          • 11 Paid Holidays
          • Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates
          • 401(k) with Company Match
          • Medical, Dental, and Vision Insurance Options Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.The salary range for this role is $145-$155K.This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range.This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.#LI-MX1When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerfulDanaher Business System(https://www.danaher.com/how-we-work/danaher-business-system)tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are availablehere(https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

Keywords: Danaher Corporation, Los Angeles , Manager, Regulatory Affairs, Genomics Medicine, Executive , Los Angeles, California

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