Director, Regulatory Strategy at Mallinckrodt Pharmaceuticals in Bedminster, New Jersey

Job Description:

Job Title

Director, Regulatory Strategy

Requisition

JR000011422 Director, Regulatory Strategy (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Hampton, NJ

Job Description

Summary

Serves as a key regulatory interface with FDA and other Health Authorities and acts as global regulatory lead for product brand teams to develop, maintain and obtain alignment of global regulatory strategies in accordance with business plans. The incumbent is expected to exhibit leadership behaviors consistent with level and to act with a high degree of flexibility and prompt response in a fast-paced work environment. In addition, the role ensures compliance with global regulatory requirements and proactively anticipates and mitigates regulatory risks.

Principal Responsibilities

* As Global Regulatory Lead (GRL), leads the global regulatory project team for development and marketed products. Key internal leader and driver of regulatory objectives and strategy for assigned products.

* Responsible for preparation and maintenance of written global regulatory strategy plans, risk registers and mitigation plans and written assessments of product probability of regulatory success.

* Leads preparation of US and Global regulatory dossiers for new product registrations and supplements, variations and amendments for assigned products. Prioritizes project deliverables and ensures that submission timelines are realistically prepared and met.

* Ensures the key deliverables for the role: regulatory support of clinical development for new indications, overall regulatory strategy for manufacturing initiatives and management of label updates. Communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out regulatory objectives thereby ensuring that corporate product goals are met.

* Works independently on complex issues under the direction of senior regulatory leadership. Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives. Ensures that regulatory documents are organized and archived in accordance with all applicable regulations.

* May participate in or lead departmental and business development initiatives. Provides coaching and mentoring for global regulatory project team members. Advances the organization's goals by participating in professional associations, industry and trade groups as appropriate. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc.

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* Provides input to Resource forecasting for projects, encompassing internal staff as well as external vendors

Minimum Requirements

Experience / Skills:

* Bachelor degree; preferably in a scientific or technical field; advanced scientific-related degree strongly preferred; Masters degree in Regulatory Affairs (or equivalent) desirable

* RAC Certification desirable

* 10 years drug/device development experience with a minimum of 7+ years in regulatory

* Global and strategic experience preferred

* Experience leading teams, mentoring or managerial experience a plus

* Rare disease or specialty pharmaceutical experience preferred

Competencies:

Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.

Ability to establish and maintain collaborative relationships with key employees in Regulatory, R&D, and Medical Affairs; Quality Assurance; Operations; Commercial and Legal, as well as positive interactions with senior management. Able to lead interdisciplinary teams including partner organizations.

Experience with leading efforts to prepare Marketing Authorization submissions, achieve successful approval, and launch. Expertise with Health Authority Meetings and negotiations.

Working knowledge of all aspects of regulatory affairs, including CMC, clinical development, statistical concepts, toxicology and non-clinical research, pharmacovigilance aspects and operations; FDA & EU guidelines and regulations with an emphasis registration requirements; experience with Rest of World submission requirements. Detailed knowledge of content and preparation of all regulatory documents and experience in maintaining regulatory compliance within pharmaceutical industry. Broad experience with multiple therapeutic area(s) and understanding of business impact of regulatory strategies.

Experience in leading teams and managing junior staff, either directly or indirectly in matrix environment; including coaching & mentoring, setting priorities, giving feedback and positively engaging cooperation. Addresses issues and challenges rapidly and in a proactive and positive manner.

Knowledge of EDMS systems, regulatory publishing, preparation of regulatory submissions and expertise with Microsoft Office programs

Organizational Relationship/Scope:

Reports to Platform/Cluster Lead

Working Conditions:

Standard Office environment with minimal (10%) travel.

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