Assertio Therapeutics, Inc.

Sr. Director / VP, Regulatory Affairs

Location
Lake Forest, IL, United States
Posted
Apr 12, 2018
Ref
1066XX
Required Education
Masters Degree/MBA
Position Type
Full time
JOB SUMMARY
Responsible for overseeing both the strategic and operational aspects of the regulatory objectives for all commercial products and R&D projects within the organization, including the timing/sequencing of regulatory milestones as well as the preparation, review and evaluation of documents for submission to health care regulatory authorities.

ESSENTIAL JOB FUNCTIONS
• Leads the regulatory affairs function with responsibilities for the oversight and implementation of regulatory strategy and activities to meet regulatory requirements for existing pipeline assets and commercial products
• Formulates and oversees implementation of regulatory strategy and activities needed to secure approval of new drugs and new indications for existing drugs.
• Leads regulatory activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials.
• Serves as the primary contact with key personnel in FDA CDER review divisions, OPDP and ex-US regulatory bodies
• Develops proposed product labeling working with Marketing, CMC, Clinical Development, Nonclinical Development and Pharmaceutical Development.
• Plans, coordinates and leads meetings with Regulatory Authorities (e.g., Pre-IND, End of Phase 2, pre-NDA meetings)
• Provides regulatory leadership for due diligence activities and product/company integrations.
• Manages coordination, preparation and timely submission of regulatory documents.
• Works collaboratively across functions and teams to develop and implement the Company's regulatory strategies and respond to health agencies, as needed.
• In conjunction with project/program team leaders, ensures budgetary and operational goals are met.
• Leads and manages constructive interactions with project team members, consultants, contractors and regulatory agencies to ensure all project/programs have clearly defined regulatory paths and milestones leading to successful filings and approvals.
• Develops and maintains relationships with external vendors and health care regulatory authorities.

ADDITIONAL RESPONSIBILITIES/DUTIES
• Serves as an integral member of the due diligence team to assess potential licensing and acquisition opportunities in terms of risks, activities and costs associated with Regulatory Affairs
• Serves as an integral member of the product integration team to ensure appropriate integration of new products into Depomed

Requirements

EDUCATION AND EXPERIENCE
• A MS/PhD with 10+ years of experience in regulatory affairs in the pharmaceutical industry with at least 5 years in a leadership role with lead regulatory responsibilities in a commercial organization.
• Experience with regulatory processes, including meeting request procedures, preparation and submission of briefing documents, annual and other updates and IND and BLA submission requirements both with the FDA and EMA.
• Track record of NDA/BLA filings
• Experience with effective project team leadership and management oversight.
• Possesses well-grounded knowledge of regulatory affairs principles, practices and systems, especially in the areas of commercial drugs and lifecycle management.
• Fluent knowledge of all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance and documentation.

SKILLS AND ABILITIES
• Is a creative, analytical problem solver, who acts decisively, yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made.
• Able to work across multiple functions and geographies (e.g., US and non-US).
• Excellent communication (written and verbal) and presentation skills.
• Effective delegation of responsibility and authority, as needed.
• Attracted to a life sciences biotechnology environment with potential for future continued growth
• Strong time management, process and project management, interpersonal and organizational skills.
• Experience with and maintenance of a good working relationship with multiple divisions within the FDA is strongly preferred.
• Strong management skills
• Excellent teamwork and collaboration skills
• Solution oriented with the ability to multi-task
• Outstanding written and verbal communication skills

OTHER REQUIREMENTS
• Travel up to 10-15% (domestically and internationally)
• Ability to direct the day-to-day work of others and the ability to recruit, develop and retain high performing employees.
• Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
• Ability to organize and prioritize work schedules of others on a long-term basis
• Ability to make decisions which have significant impact on the Company's reputation, credibility, operations and services.
• Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications and make formal presentations.

DEPOMED COMPETENCIES INCLUDE
• Decisions and Judgment: independently completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
• Ownership and Initiative: Assumes personal ownership and accountability for business results and solutions. Organizes work based on company/department goals. Develops alternative strategies when confronted with obstacles. Plans and organizes work so that timelines are met or exceeded.
• Communication skills: Expresses ideas and information effectively and constructively. Provides accurate and timely information to others within the department and across functional groups. Demonstrates attention to and understanding of others' comments, questions, and views.
• Leadership: Articulates a clear direction and demonstrates the ability to motivate and positively influence others. Effectively manages people, projects, and budgets. Clearly defines performance standards for employees and gives recognition when appropriate. Ensures employees have clear measurable goals aligned with organization's priorities and holds people accountable for results. Addresses performance and behavior issues in a timely manner. Inspires people to excel by modeling excellence and enthusiasm. Empowers teams to solve problems and initiate improvements. Identifies organizational needs and attracts, selects and retains talent.

About Us

THE COMPANY
Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.

Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Depomed has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

As part of the transformation strategy, Depomed will be relocating its headquarters to the northern suburbs of Chicago, Illinois. Additional information about location will be shared during the interview process.

Depomed is an AA/EEO/Veterans/Disabled employer