Deputy Head of Product Development and Regulatory Affairs

Deputy Head of Product Development and Regulatory Affairs

Scendea is seeking a highly motivated individual to join our global team as a full-time Deputy Head of Product Development & Regulatory Consulting, at either Senior Consultant or Principal Consultant level. This is a hybrid position, based in the UK, Netherlands, US, or Australia, requiring a minimum of one day per month in the office. The role reports to the Head of Product Development & Regulatory Consulting.
This is an excellent opportunity to advance your career within a rapidly growing Regulatory Consultancy, playing a key role in staff development and providing high-quality regulatory and product development advice to clients.
Role Requirements

Support the leadership in managing the global operational team and ensuring high-quality, timely client deliverables.
Provide guidance, coaching, and remove obstacles to project delivery.
Assist with project management, client account development, and expansion strategies.
Deliver strategic regulatory advice to facilitate clinical trials and international marketing approvals, maintaining high technical knowledge in product development and regulatory affairs.
Prepare and review regulatory documentation such as Regulatory Strategy Plans, Clinical Trial Applications, INDs, Marketing Applications, etc.
Lead multi-jurisdictional programs and deliver consulting services within your expertise.
Ensure project goals are met within timelines and budgets, and lead stakeholder meetings.
Support business development efforts and generate new client opportunities.
Manage, train, and mentor team members, providing technical leadership.
Develop systems and procedures to improve operational efficiency.
Analyze issues and develop corrective strategies to ensure quality and timeliness.
Contribute to SOP development and training materials.
Review estimates, quotations, and contracts, assisting with contractual translations.
Participate in senior leadership to support company goals.
Skills and Experience

Relevant science degree (BSc, MSc, or PhD) in biomedical or related fields.
At least 8 years (Senior Consultant) or 10 years (Principal Consultant) of drug development and regulatory experience.
Experience working with regulatory agencies such as FDA, EMA, MHRA, or TGA, including meetings and negotiations.
Minimum 5 years of team management experience.
Broad medicinal product development experience across various indications, with strategic regulatory planning expertise.
Proven leadership and training abilities, with experience presenting at scientific conferences.
Excellent organizational, communication, and computer skills.
Willingness to travel and work flexible hours.
Benefits include bonuses, holidays, pension, private healthcare, Employee Assistance Programme, and Employee Ownership Trust Scheme.
About Scendea

Scendea is an international consultancy specializing in product development and regulatory solutions, committed to advancing healthcare innovation globally. We value transparency, ethics, and employee involvement, fostering a supportive and inclusive culture.
Eligibility & Conditions

Applicants must reside and be eligible to work in the UK, Netherlands, US, or Australia without sponsorship. The application deadline is June 13, 2025, with notifications by June 17, 2025.

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