Manager Regulatory Affairs Submissions

Johnson & Johnson

4.2

(92)

High Wycombe, United Kingdom

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2506230696W

    Position summary

    we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://https://www.jnj.com/.

    Key Responsibilities:

    • Be responsible for the submission, operational management, and delivery of regulatory submissions at a compound level to support global development and registration, primarily focused on EUCTR Clinical Trial Applications (CTAs).

    • Create and handle dossier plans/submission packages in line with regulatory strategy, seeking input from regulatory therapeutic areas, functional area representatives, and vital collaborators, while providing guidance to project team members

    • Contribute to decisions that have an impact on the quality and timeliness of moderate to sophisticated Health Authority submissions

    • Make decisions on submission operational strategies for the best project management approach within process/timeline/resource constraints.

    • Lead Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.

    • Take a leadership role for the monitoring and efficiency of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.

    • Cultivate effective relationships, maintaining open communication with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.

    • Develop departmental work practices, process enhancements / improvements, and associated training materials

    • May be responsible for performance and development of direct reports.

    Qualifications

    Qualifications, Experience and Skills:

    • University/bachelor's degree and 6 years of related professional experience, or

    • Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience

    • In-depth understanding of drug development process

    • Ability to demonstrate in-depth knowledge of regulatory submissions, filings, and processes

    • Ability to work and lead in a matrix environment

    • Proven ability to build positive relationships and influence stakeholders across an organization

    • Proficiency in relevant submission-related Health Authority and Industry regulations and guidelines

    • Proficient use of Regulatory Information Systems

    • Fluency in English; other languages may be required depending on assignment.

    • Validated project or submission management capabilities

    • Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of submissions and filings

    Preferred

    • At least 5 years of Regulatory Affairs experience

    • Experience associated with leading EUCTR Clinical Trial Applications

    Other

    • May require up to 5% travel, domestic and international.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.