Director, Regulatory Sciences
- Fleminggatan 18, 112 26 Stockholm, Sweden
- Employees can work remotely
Southwood Research, a ProPharma Group company, is a leading provider of pre-approval regulatory science services to the pharmaceutical and biotech industries.
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The Director, Regulatory Sciences will formulate regulatory strategies and recommendations for the resolution of complex issues for clients and will lead the process in the development of regulatory submission, including but not limited to; MAA’s, Orphan and PIP applications, Accelerated and Conditional approvals. Additionally, the Director, Regulatory Sciences will pro-actively identify new regulatory trends and challenges and predict the effect of changes on regulations, policies and procedures. They will conduct due diligence on behalf of clients and develop risk management recommendations, build collaborative relationships with key stakeholders and manage the internal and external teams responsible for delivery and develop junior associates.
Essential Functions Include:
- Leading the development and implementation of regulatory strategies to realise the commercialisation of healthcare products.
- Strategic project shaping and leading of process preparation for EMEA submissions.
- Review and approval of audit and submission documentation.
- Briefing of clients and internal project teams.
- Leading and influencing frequent interactions for pre-submission activities with both EMA and national regulatory agencies.
- Leading client meetings and conducting client liaison on an ongoing basis.
- Provide scientific insight for new business pitches and proposals.
- Line management for junior team members.
Qualified candidates must have:
- Post graduate degree in a life sciences discipline.
- Minimum of 5 years Regulatory and EMEA submission experience.
- Excellent knowledge of the pharmaceutical industry.
- Strong English writing and communication skills.
- Strong scientific and analytical ability.
- Keen consultancy skills in handling clients.
- Ability to manage organizational change.
- Oncology, heamatology, orphan diseases and immunology experience preferred.
- Excellent interpersonal skills.
- Sharp attention to detail.
- Flexibility to move quickly between projects and work across different therapy areas.
- A positive can-do attitude.
- Ability to work independently and pro-actively lead a project team.
- Line management experience.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***