The Regulatory Affairs Manager is responsible for regulatory compliance, product registration, labeling, and advertising compliance for the company both internationally and domestic.
- Has a desire to function as a team member by listening, asking questions, collaborating, and contributing on daily basis.
- Comfortable with prioritizing and managing multiple assignments.
- Demonstrates a flexible and collaborative approach with various cross-functional teams.
- Able to draw on diplomatic communication skills
- M.S. in Regulatory Science or a related technical field preferred.
- Minimum 10 years knowledge and experience in Regulatory Affairs in the manufacture and distribution of pharmaceutical products and sterile, disposable medical devices.
- Thorough understanding of FDA QSR (21 CRF 820), medical device manufacturing and ISO/EC (MDD, CMDR, ISO 13485) requirements.
- Thorough understanding of the CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals.
- Knowledge of pharmaceutical industry regulatory affairs throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations.
- Capability to respond to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
- Ability to interpret Regulatory Authority policies, guidance and correctly apply them as appropriate in product development.
- Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
- Ability to review detailed scientific information and assess whether technical justifications 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.
- Formulate and lead regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
- Proactively communicate regulatory strategies, key issues and any other critical topics throughout the life cycle.
- Lead submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits.
- Identify and prepare regulatory submissions for approval (i.e. 510k).
- Act as company management representative during on site Quality System audits by regulatory agencies and customers.
- Maintain Establishment Registrations, Device Listings and State Licenses both Domestic and International.
- Generate annual medical device management review and drug annual reports.
- Ensure the appropriateness of regulatory standards referenced within Quality System, maintain updated standard library and conduct GAP/risk analysis to determine impact of standard changes/revisions.
- Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products.
- Review quality documents (operational procedures, work instructions, validations, etc.) including but not limited to protocols, for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development strategy.
- Other responsibilities as assigned
Physical and Environmental Elements
Physical demands: Ability to sit continuously for up to 2/3 of normal work shift. Ability to stand, walk, stoop, kneel, crouch or crawl, and to reach with hands and arms occasionally. Ability to talk and to hear continuously. Ability to lift up to 25 pounds periodically. Finger dexterity is required frequently for up to 1/3 of the normal work shift.
Vision: Ability to see at close range (20 inches or less), at a distance (clear vision at 20 feet or more), ability to identify and distinguish colors, ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, three-dimensional vision, ability to judge distances and spatial relationships, and ability to adjust the eye to bring an object into sharp focus.
Work Environment: Employees work in an office with moderate noise levels (such as computers and printers) and controlled temperature conditions. Employees may occasionally operate a vehicle and be exposed to traffic conditions that may include loud noises, fumes, and traffic congestion.
- Valid California Driver License and driving record that allows insurability.
- Ability to pass a general background check.