Regulatory Affairs Manager

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Recruitment Consultant at SThree | Georgia Tech Scheller College of Business Alumni

Regulatory Affairs Manager

Marketed Products Development, Growth and Emerging Markets

Defines, develops and leads GEM strategies to maximize regulatory success to strengthen the product development plan, to enable patient access and to achieve appropriate price and reimbursement in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application, and life-cycle management.

Key Responsibilities:

• Collaborates to define, develop and lead Marketed Products GEM strategies to maximize regulatory success towards achievement of program objectives.
• Independently manages, plans and executes all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program.
• Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.
• Stays current with regulations / guidances in Growth and Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
• Provides regulatory expertise on Marketed Products in GEM for multiple projects, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management.
• Assures ongoing efforts towards fulfilment of international product approval conditions for late stage programs.
• Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company’s consultants and Business Partners.
• Evaluates new business development opportunities for Growth and Emerging Markets and / or participates on due diligence teams.
• In coordination with local regulatory lead provides strategic guidance / advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
• Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents the company’s GEM RA in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required.
• Manages, trains, provides direction, strategic guidance and solutions to projects, mentors team members, to support scope of project work.
• Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
• Responsible for demonstrating the company’s leadership behaviors.

Main Tasks:

• Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving).
• Take initiative and coordinate resources to drive tasks to deadlines.
• Demonstrate technical and solutioning skills, influence decision making to feasible solutions.
• Use collaboration skills and partnerships to work within the agreed Governance model.
• Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships).
• Confidently engage with external vendors and manage internal stakeholders, representing the needs of the BU.
• Express self clearly and concisely at all levels, in both verbal and written communication.
• Demonstrate maturity of thinking.
• Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement.
• Create and deliver clear and professional presentations with appropriate messaging and focused recommendations.
• Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking).
• Apply most current expedited regulatory pathways and leverage worksharing among regulatory agencies utilizing a tailored approach for assigned programs.
• Foster a culture of best practice and knowledge sharing.
• Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations).
• Understand the changing needs and priorities of the business.
• Understand complex issues and to propose timely, cost-effective and achievable solutions, whilst being mindful of flexibility rather than a „one size fits all“ approach.
• Work in a fast-paced environment with demonstrated ability to delegate and juggle multiple competing tasks and demands, often with a degree of ambiguity.

Key Requirements:

• Bachelor’s degree in a scientific discipline; BA accepted based on experience. Advance degree preferred.
• Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases.
• 4 years of directly related regulatory experience is desirable.
• Solid regulatory experience, including knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets; and US and EU (relevant to role), including interaction with Health Authorities.
• Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
• Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Generally strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership.
• Effective manager who is able to bring working teams together for common objectives.
• Experience managing relationships with external vendors and/or contractors is also preferred.
• Willingness to travel to various meetings, including overnight trips.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research

Industries

Manufacturing

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