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Head of Global Regulatory Operations
2 months ago
The Director of Regulatory Strategy plays a pivotal role in overseeing the assigned brand initiatives and making all strategic decisions, including outlining the regulatory pathways for development. This position entails engaging with regulatory agencies, collaborating effectively with Contract Research Organizations (CROs), and liaising with various stakeholders as necessary. The role is designed to be hybrid, allowing for a blend of in-office and remote work.
Key Responsibilities
- Act as the primary regulatory contact and provide essential regulatory insights for the US market and other relevant markets.
- Offer strategic, tactical, and operational leadership for the product pipeline and significant regulatory milestones.
- Develop, implement, and uphold the regulatory commitments and requirements for designated programs.
- Stay informed about regulatory agency regulations, directives, guidelines, and policies that may influence product development and approval pathways.
- Identify and communicate potential issues to management that could affect product submission, approval, and market launch.
- Establish and monitor submission timelines in collaboration with key stakeholders.
- Lead all communications with Regulatory Agencies and Health Authorities as required.
- Ensure that all communications with regulatory bodies adhere to established departmental procedures.
- Facilitate discussions between other functional areas and Health Authorities, ensuring that the Regulatory Strategist/Lead is the main point of contact.
- Ensure documentation of communications is distributed within the Global Regulatory Affairs team and any other affected departments.
- Engage in writing or facilitating the authorship of specific regulatory sections of product submissions.
- Build and maintain relationships with external regulatory agencies, industry organizations, and business partners.
- Review audit reports, Regulatory Agency inspection reports, and responses to any inspection observations when received.
- Compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
- Conduct departmental training to educate regulatory strategists and other roles on regulatory requirements, policies, and procedures.
- Participate in the authorship and/or review of departmental procedures as necessary.
Qualifications
- A post-graduate degree in Clinical Pharmacy or a related field is required.
- A PhD is preferred.
- A minimum of 10 years of experience in global regulatory affairs within the pharmaceutical or biotech sectors.
- Comprehensive understanding of the New Chemical Entity (NCE) drug development process and regulatory requirements for various administration routes, including Topical Dermal, Ophthalmic, and Parenteral.
- Direct experience in authoring and filing IND, CTA, NDA, and BLA submissions across major regulated markets, along with knowledge of evolving biologics regulations.
This position is part of the Annual Performance Bonus Plan and may qualify for the Long-Term Incentive Plan. Employees are eligible for various company benefits, including medical, dental, and vision coverage, life and disability insurance, retirement savings plans, flexible spending accounts, and employee assistance programs. Additionally, employees receive paid time off benefits, including vacation and sick leave.
The compensation and benefits outlined are subject to the terms and conditions of governing plans, policies, and agreements in effect from time to time, including eligibility criteria. If hired, the employee will be in an 'at-will position,' and the company reserves the right to modify base salary and other compensation programs as needed, based on individual performance and market factors.
The preceding job description has been tailored to reflect the expectations and responsibilities associated with this role.
