Global Regulatory Strategist - Remote - Contract
Proclinical is seeking a Global Regulatory Strategist who will play a key role in our regulatory affairs team. This is a remote contract position.
Primary Responsibilities:
The successful candidate will be responsible for representing regulatory affairs in assigned due diligences, contributing to the diligence process, and making regulatory recommendations. Additionally, the role may involve representing the company to regulatory authorities and corporate partners, and managing regulatory strategies for specific products within a therapeutic area.
Skills & Requirements:
- Minimum Scientific Degree (BSc, or MD, PhD, PharmD, MSc) or equivalent experience in drug, device, development and commercialization.
- Demonstrated experience in drug development.
- In-depth and relevant Global regulatory experience (in US, Europe and other regions).
- Experience in regulatory due diligence activities.
- Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Direct experience in interfacing with regulatory authorities.
- Strong organizational skills, including the ability to prioritize personal workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
The Global Regulatory Strategist will:
- Participate in internal diligence teams, providing strategic and technical regulatory guidance for external diligences.
- Develop and maintain in-depth regulatory knowledge of the disease areas of each due diligence.
- Assess public and company confidential information to inform on and make recommendations.
- Provide a regulatory recommendation to proceed with diligence, in collaboration with the Global Regulatory Strategy Lead (GRSL).
- Identify and progress global regulatory strategies for a product within the assigned portfolio.
- Work closely with regulatory colleagues across therapy areas to ensure consistent approaches to Health Authorities.
- Identify and assess regulatory risks associated with product development and define strategies to mitigate risks.
- Provide regulatory guidance to company personnel throughout the research and development process.
- Liaise with regulatory leads to ensure submissions are made, and potentially prepare submissions.
- Advise on global CTA submission strategy.
- Monitor and analyse regulatory agency activities and assess impact on programs.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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