Valeant Pharmaceuticals

Sr. Manager, Regulatory Affairs-Surgical

US-MO-O’Fallon
Job ID
9267
Category
R&D
Pos. Type
Full Time

Overview

The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities.

Responsibilities

Responsibilities may include but are not limited to:
 Responsible for developing a global product regulatory strategy for surgical devices
 Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
 Develop a product regulatory timeline aligned to Bausch & Lomb’s product development, with key regulatory milestone, and activities for agency filing
 Coordinate with the team on the development of product labels
 Ensure labeling content and product documentation is developed in accordance with regulatory requirements
 Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
 Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities
 Act as a regulatory contact for assigned country Regulatory Authorities for surgical devices
 Liaise with Bausch & Lomb country-specific surgical Regulatory Affairs personnel for international submissions and registrations
 Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections
 Provide regulatory guidance/input to surgical device change control and internal product review boards
 Manage assigned personnel
 Other job responsibilities as needed.

 

 

Supervise direct reports:  Yes

 

Scope of Position:  Support all North America – Surgical sites.

 

Key Relationships:

 

Internal Customers/Business Partners:

  • Quality Assurance
  • Research and Development
  • Manufacturing
  • Global Product Surveillance and Safety
  • Commercial Teams
  • Medical and Clinical Affairs
  •  External Customers/Business Partners:
  •  Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
  • MDs/ODs

 

External Customers/Business Partners:

 

Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

MDs/ODs

Qualifications

Technical Competencies:

• Knowledge of surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
• Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices
• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
• Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices
• Ability to influence and partner with cross-functional teams in a global surgical organization
• Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
• Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

 

Professional Competencies:

• Demonstrated ability in analytical reasoning and critical thinking skills
• Strong capability to contribute and lead a team environment
• Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
• Excellent communication skills; both oral and written
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Capacity to react quickly and decisively in unexpected situations
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Focused ability to influence operational excellence and performance metrics
• Risk adverse where needed with the ability to identify potential solutions to complex problems

 

Experience:

 

• 10+ years relevant medical device industry and regulatory experience
• Ophthalmic Surgical device regulatory experience highly preferred
• Bachelor’s degree in science or health related field
• Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

Be Aware of Recruiting Fraud

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

 

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