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Director Regulatory Affairs Advertising and Promotion
This position is remote and can be based anywhere in the U.S.
What Reg Affairs contributes to Cardinal Health
Regulatory provides regulatory affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. This function applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting.
Regulatory Affairs plans, coordinates and implements regulatory strategies for products that require government approval. This job family proactively identifies regulatory requirements and risks for products and develops plans for product development programs and regulatory submissions.
– In collaboration with the key cross-functions (marketing, legal, R&D, RA, Medical and Clinical Affairs), develop an overarching global claims strategy (content and substantiation) for all clinical solutions across the Medical Device Segment.
– Utilize marketing and regulatory intelligence to closely monitor competitive landscape to strategize and lead the effort to activate new and enhanced claims across all medical device portfolio.
– Maintain regulatory responsibility to strategize, operationalize consistency in review and approval of all marketing and promotional materials.
– Responsible for maintaining source of truth for all portfolio centric claims matrices.
– Owner of the overall policies and procedures associated with advertising and promotion of medical devices.
– Lead, organize, and maintain oversight of various departmental training programs with significant emphasis on “fair and balanced” representation of portfolio and clinical solutions.
– Responsible for maintaining knowledge of all current and evolving laws, regulations, and policies relevant to advertising and promotion of medical devices.
– Enable strategic regulatory compliance of global advertising and promotional materials with the established process and procedures, product labeling, and evolving market-centric regulatory requirements.
– Lead and support all internal and external audits and reviews of advertising and promotion related materials and activities.
– Responsible for content review and approval of all external facing materials, such as press release, web sites, social media posting, marketing brochures, materials related to speaker events etc.
- Bachelors and Advanced degree in related field, or equivalent work experience, preferred
- 12+ years experience in related field, preferred
What is expected of you and others at this level
- Utilizes broad and deep knowledge to develop innovative new business practices, policies and procedures
- Contributes to the development of department strategy
- Works on or may lead highly complex projects of large scope
- Projects are typically cross-functional and have significant and long-term impact
- Provides solutions which set precedent
- Negotiates complex or risky technical business issues on behalf of the company
- Independently defines project establishes budgets identifies participants and mitigates risk
- Consults with management to determine project objectives with long-term implications
- Acts as a mentor to less experienced colleagues
In the State of California –
A Covid-19 vaccination or a legitimate accommodation is required in order to be employed in this position. Covid-19 vaccination includes:
2 doses of the Moderna or Pfizer vaccine / 1 dose of the Johnson & Johnson vaccine
1 booster dose of the vaccine (Johnson & Johnson, Moderna, or Pfizer)
Anticipated salary range: $120 – $175K
Bonus eligible: Yes
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
Job posted: 2022-07-18