Director, Regulatory Affairs

Scorpion Therapeutics; United States; Remote; USD 130,000 - 180,000; Full time

Job summary

A leading pharmaceutical company is seeking a Director of Regulatory Affairs to oversee regulatory development and ensure compliance for prescription products. The ideal candidate will have extensive experience in the pharmaceutical industry and a strong understanding of regulatory affairs. Join a dedicated team committed to improving health outcomes and making a difference in patients' lives.

Benefits

Comprehensive Medical (includes Prescription Drug)

401(k) matching

Tuition reimbursement

Paid holidays

Employee referral bonuses

Qualifications

• 10+ years relevant pharmaceutical industry and regulatory experience.
• Knowledge of domestic and international laws affecting pharmaceutical products.
• Ability to interpret Regulatory Authority policies.

Responsibilities

• Coordinate and oversee regulatory development and post-approval activities.
• Establish product regulatory strategy for assigned therapeutic area.
• Manage interactions with Regulatory Authorities.

Skills

Regulatory Affairs

Pharmaceutical Industry Knowledge

Project Management

Education

Bachelor’s degree in science or health related field

Job description

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Join a Team!

We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

Job Scope:

The Director of Regulatory Affairs coordinates and oversees regulatory development and post-approval regulatory activities for prescription products of assigned portfolio. Active member of the product development team to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for pharmaceutical products. May perform due diligence efforts on new product opportunities.

Key Responsibilities:

• Responsible for establishing a product regulatory strategy for pharmaceutical products in the assigned therapeutic area.
• Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development.
• Ensure that development and execution of product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestones, and activities for agency filing.
• Ensures regulatory deliverables are in place and delivered to time cost and quality pre- and post-approval dossier management.
• Ensures that data are identified, obtained, and effectively presented for successful filing, approval, registration, market launch, maintenance of business and regulatory compliance.
• Active member of product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions.
• Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities.
• Manage interactions with other BHC functions (e.g., Quality, Compliance) during Regulatory Authority inspections.
• Provide regulatory guidance/input to internal product review boards.
• Manage assigned personnel if applicable.
• Requires three days/week onsite in the Bridgewater, NJ office.
• Occasional travel may be required.

Qualifications:

• Bachelor’s degree in science or health related field.
• 10+ years relevant pharmaceutical industry and regulatory experience.
• Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle.
• Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical 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 pharmaceutical products.

Benefits:

The benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, military and/or veteran status, or any other Federal or State legally protected classes.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to [e-mail] or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

Job Offer Scams:

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 Job Offer Fraud Statement.

Bausch Health is an EEO/AA employer M/F/D/V.