Senior Regulatory Affairs Director - Global Reg Strategy

Propharma

4+ years

Not Disclosed

Remote, USA

10 Aug. 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy

Location: Remote (Contractor Opportunity)

Company: ProPharma Group

About ProPharma:

For the past 20 years, ProPharma has been enhancing patient health and wellness by providing expert advice and services that empower biotech, medical device, and pharmaceutical organizations of all sizes. As the world’s largest Research Consulting Organization (RCO), we support our clients through an advise-build-operate model across the entire product lifecycle. Our deep expertise spans regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, offering a fully customizable suite of consulting solutions designed to de-risk and accelerate high-profile drug and device programs.

Job Summary:

The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy, will oversee the development and implementation of global regulatory strategies for products in the Cell Therapy Immunology area. This role is crucial for achieving successful product registration and lifecycle management, ensuring patient needs are met effectively.

Key Responsibilities:

Regulatory Strategy: Provide strategic oversight for regulatory activities related to assigned products and projects, ensuring alignment with overall enterprise objectives from initial registration through lifecycle management.
Leadership: Lead cross-regulatory teams and provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs). Represent the client in interactions with Health Authorities and other relevant stakeholders.
Regulatory Guidance: Support staff in preparing for regulatory meetings, submission strategies, and critical regulatory documents. Offer strategic advice on procedural and operational issues.
Collaboration: Work closely with Senior Management and Enterprise functions (Clinical, Commercial, Medical Affairs, etc.) to offer regulatory insights and drug development expertise.
Compliance: Stay current with the latest regulatory requirements and trends, ensuring compliance and providing support for Business Development activities, including regulatory due diligence and resource needs.
Ethics and Leadership: Demonstrate exemplary behavior and leadership, maintaining transparency and ethical standards within the organization and with external stakeholders.

Essential Qualifications:

Education: Bachelor’s Degree in a scientific or pharmaceutical discipline.
Experience: 10+ years of regulatory experience in the pharmaceutical industry, with a proven track record in developing and implementing global strategies.
Expertise: Strong knowledge of drug development and regulatory policies, particularly in immune-mediated diseases or complex therapy areas. Experience with global jurisdictions such as the EU, US, China, and Japan through all stages of development.
Skills: Excellent scientific and business judgment, ability to manage complex issues and coordinate multiple projects, and strong interpersonal and communication skills.
Knowledge: Highly knowledgeable of new and emerging regulations and guidances. Understanding of GxPs and the ability to interpret regulatory information effectively.
Cell Therapy: Experience in cell therapy development is a plus.

Work Environment:

Recognizing the importance of flexibility, ProPharma offers remote working opportunities with a requirement to engage face-to-face in our offices 3 days a week. This approach allows employees to balance personal and work commitments while fostering a collaborative and team-oriented culture.

Diversity and Inclusion:

ProPharma celebrates diversity and is committed to creating an inclusive workplace where everyone can be their authentic selves. We encourage employees to unleash their innovative, collaborative, and entrepreneurial spirits, and provide a safe space where all employees are empowered to succeed.

Application Instructions:

ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please refrain from calling or emailing regarding this posting.

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Senior Regulatory Affairs Director - Global Reg Strategy

Job Description

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