Valeant Pharmaceuticals

Regulatory Affairs Manager

US-CA-Irvine
Job ID
9239
Category
R&D - Regulatory Affairs
Pos. Type
Full Time

Overview

The Regulatory Affairs Manager handles all regulatory development aspects for prescription and assigned OTC drug products and cosmetics for the Obagi franchise. Participates in product development to provide regulatory guidance for assigned products. Manages relevant regulatory strategy components and interactions with US FDA, and international registration, as needed for assigned products. May perform due diligence efforts on new product opportunities.

Responsibilities

 Responsible for developing a product regulatory strategy for assigned products (may include NDA strategy for new compounds/formulations).
 Interact with global regulatory agencies, or colleagues/associates, to determine approporiate regulatory requirements to register products or address gaps.
 Develop a product regulatory timeline aligned to Obagi’s product development, with key regulatory milestones, and activities for agency filing, if required.
 Coordinate with the Labeling/Promotional group for the development of product labels and support of promotional materials
 Ensure labeling content and product documentation is developed in accordance with regulatory requirements
 Participate in product development to ensure awareness of US FDA and international requirements and timing for submissions or drug listing.
 Ensure timely and accurate submissions to Regulatory Authorities as needed
 Act as primary regulatory contact with Regulatory Authorities for assigned products
 Liaise with pharmaceutical Regulatory Affairs personnel outside the US (or CROs) to achieve international submissions and registrations
 Manage interactions with other Obagi functions (e.g., Quality, Compliance) during Regulatory Authority inspections
 Provide regulatory guidance/input to promotional review team
 Manage assigned personnel or contractors
 Other job responsibilities as needed

Qualifications

 Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
 Knowledge of domestic and international laws, regulations, and guidance that affect current or potential Obagi products
 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 Obagi products
 Ability to influence and partner with cross-functional teams
 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

 

Experience:

 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-averse where needed, with the ability to identify potential solutions to complex problems
 10+ years relevant pharmaceutical industry and regulatory experience
 OTC and cosmetic experience highly preferred
 Bachelors degree in science or health related field
 Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed