Senior Regulatory Affairs Strategist; or office based

Position: Senior Regulatory Affairs Strategist (home or office based)
Location: Via Milano

When our values align, there's no limit to what we can achieve.
Parexel is seeking an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining market approvals across international regions. You will provide expert guidance to our clients and delivery teams while managing multiple projects in a fast-paced, results-oriented environment.
The role can be home or office based in various European locations.

Key Responsibilities:

Strategic Leadership

Develop comprehensive international regulatory submission strategies for a wide variety of products and projects including CTAs, MAAs and Lifecycle management.
Provide strategic guidance to clients and delivery teams on requirements and submissions across international regions
Support or act as Project Lead, working with local market Regulatory Affairs experts to optimize strategies for specific submissions

Submission Management

Guide delivery teams in the creation and maintenance of international dossiers
Drive and manage multiple regulatory submissions simultaneously
Ensure effective regulatory representation in partnership with appropriate technical experts at health authority meetings
Document discussions and agreements with regulatory authorities clearly and comprehensively

Regulatory Intelligence

Monitor and stay abreast of key changes in the regulatory environment of international markets
Create and perform regulatory intelligence surveys
Communicate regulatory requirements and propose submission strategies to clients

Team Leadership

Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with quality
Identify and mitigate risks with respect to international submissions
Guide cross-functional team discussions and drive regulatory solutions

Skills and Experience required for the role:

University degree in a relevant scientific discipline (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences)
10+ years of experience in the pharmaceutical / biotech industry, with substantial experience in Regulatory Affairs
Broad background in pharmaceutical business and experience in several areas within regulatory affairs (e.g., Global, European, International, Marketing Company or health authority experience)

Experience with biologics / vaccines / infectious diseases / oncology and rare diseases strongly preferred
Leadership in managing regulatory agency negotiations and organizing Scientific Advice Meetings with health authorities
Strong knowledge of CTD format and eCTD submission builds, including preparation of Modules 1-5 documents

Experience with Clinical Trial Applications and regulations relating to clinical trials
Strong influencing, negotiation, and relationship management skills
Advanced problem-solving skills and drive to generate compliant regulatory solutions
Fluent English, written and spoken

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