Professional services company need a Global Strategic Regulatory affairs manager to Support the RA Partner business leading implementing global regulatory strategies for marketed brands. The assignment will be 12 months, with the likelihood of an extension.
Duties:
- Develops and implements global regulatory strategies for assigned marketed brands to meet project targets, ensure business continuity, and achieve timely approvals.
- Creates tactical plans for regulatory execution, including submission preparation, dossier assembly, procedure management, risk identification, and solution/mitigation strategies.
- Collaborates flexibly across regions, working closely with GRT Med´s subsidiaries and partners for information exchange and compliance with GRT principles and intellectual property policy.
- Adheres to standardised processes, ensuring regulatory compliance and seamless collaboration across interfaces, with a focus on data management and performance within the subteam.
- Prioritise tasks within the regulatory subteam, liaises with functional experts, and participates in cross-functional teams as needed.
- Assumes the role of RA Partner Business (PB) Lead for delegated (sub)projects.
- Monitors changes in regulatory guidelines and competitive landscape, analysing and sharing potential impacts on the life cycle and regulatory submission/procedure management.
- Supports due diligence activities for in-licensing opportunities and other projects, providing high-quality regulatory assessments for proper valuation.
Education skills and experience
- Scientific university degree (Master or PhD preferred) in life science (pharmacy, biology, chemistry, or related discipline).
- 5-7 years of experience in the pharmaceutical industry or health authority.
- Regulatory experience in a global setting, with a primary focus on CA | APAC | MENA.
- In-depth knowledge of ICH/EU/US guidelines and regulations, covering all aspects of regulatory submission and procedure management.
- Sound understanding of relevant scientific and technical aspects of drug development and life-cycle management.
Specific Skills & Knowledge:
- Excellent written and verbal communication skills in English; proficiency in German or Spanish is beneficial.
- Advocate for the added value of regulatory affairs in overall business strategy.
- Strong project management, negotiation, and leadership skills.
- Proficient in leading, coordinating, and synchronising multiple projects, overcoming obstacles, and adapting to changing daily workload priorities.
The role will be fully remote and for any candidates within the UK, the role will be inside IR35.
Please call me or send suitable resumes and I will respond immediately.
