Globla Regulatory Strategist

4 weeks ago

Maidenhead, United Kingdom ProClinical Full time

**Salary**:
Highly Competitive Salary

Job type:
ContractDiscipline:
Consultant / Specialist, Officer /Associate, RA Intelligence**Location**:
United Kingdom- Maidenhead, England
- Posting date: 23 Apr 2024

Reference:
RA.PD.60052

**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**:
**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.

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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