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.
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
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
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)