Director, Publishing and Submission Management - REMOTE

Proclinical is seeking a remote Director, Publishing and Submission Management for a leading pharmaceutical company. This position will develop and apply a comprehensive understanding of global RA regulations and guidelines on different submission types/formats (NeeS, eCTD, Paper, ACTD, eCopy, IMPD, PIP, DMF, ASMF etc.) to projects to enhance probability of regulatory success and regulatory compliance.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• You will partner with project management and functional areas to develop strategic plans for health authority submissions and interactions.
• You will also monitor global health authority regulations, guidelines, and specifications in- markets such as US, EU, EMEA, Canada, AU, CH, GCC, EAEU and APAC for regulatory submissions to ensure compliance.
• Offer expertise and guidance to Regulatory Strategy and key stakeholders to support regulatory submissions with global health authorities.
• Work with other functional managers to ensure consistency of departmental approach within the company.
• Leverage relationships with our suppliers to support business needs, support execution on business plans for the performance of the group.
• You will apply business and management expertise to drive operational performance across the Regulatory organization and be accountable for resolution of less complex operational issues and will work with the Head of Global Regulatory Publishing to resolve highly complex or unusual operational issues.
• As part of the Global Regulatory Operation (GRO) reporting to the Global Head of Publishing.
• The Director, Publishing and Submission Management will support both strategic and operational activities.

Skills and Requirements:

• Sets functional goals which contribute to department's vision and long-range planning.
• Develops effective relationships with external publishing vendors/ contractors and software providers as appropriate to facilitate effective processing of the regulatory submission workload.
• Significantly contributes to establishing budgets, schedules, work plans and KPIs.
• Makes decisions on administrative and operational matters and ensures the publishing team effectively achieves its objectives.
• Sets operational strategies for improving regulatory affairs systems/processes for the efficient publishing and archiving of regulatory submissions.
• Promotes partnerships with project/program teams to ensure the company meets all key submission milestones.
• Represents the company at relevant industry forums and/or software user groups.
• When necessary and appropriate, steps in for or lends assistance to direct and indirect reports to help drive results and achieve objectives.
• In-depth knowledge of company people management policies and procedures including hiring, performance management, corrective action, and compensation administration
• Advanced leadership skills including change management, people development, strategic thinking and influencing
• Ability to translate high level corporate strategy into long-range project plans to gain competitive advantage
• Advanced knowledge of regulatory publishing and electronic document management systems
• At least 10 years of experience in pharmaceutical/biotech industry, with 8 years of hands-on global regulatory submissions management and publishing experience.
• Bachelor of Science Degree in Technical Discipline such as Life Sciences or Health Care Professions (Engineering, Biology, Chemistry, Nursing, Pharmacy) or related discipline; Advanced degree preferred.
• At least 5 years managing individual contributors in addition to the ability to lead by influence and work effectively in matrix organizational structures
• Significant experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
• Experience with supporting and leading successful delivery of projects (pipeline, business improvement, and/or change management projects) as well as Demonstrated experience driving change / transformation projects
• Understanding of relationship management with demonstrated experience in partnering in large scale situations
• Business analytics experience and innovative thinking in order to drive insights into operations and change management and support strategic sourcing decisions.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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