Role: Clinical Regulatory Innovation Leader

Role Type: Full-Time only ( No Contractor, Temp or 3rd Party)

Location: East Coast

The Clinical Regulatory Innovation Leader position is part of the strategic group of TCS Life Sciences and will work closely with ADD regulatory product, business development and marketing teams as well as multiple life science leaders at a global level.

You will be responsible for the strategic positioning, roadmap and solution development from a business perspective for Clinical Regulatory at a global level. You will drive and co-lead thought leaderships, marketing material, advisory boards and partnerships. You will support customer presentations, industry events and RFI/RFP requests of regulatory life science leaders.

Main responsibilities and duties

• Co-leads the global strategic positioning & roadmap from a business view for solutions in regulatory submission planning & monitoring, content-dossier authoring, publishing & aggregate reporting, data anonymization, product labelling, regulatory intelligence collection & dissemination.
• Co-leads the design & development for these solutions from a business view
• Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards and represents our clients at regulatory consortia
• Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.
• Drives Health Authority engagements for innovative technology solutions.

Qualifications and education

• Master’s degree in sciences (e.g. biology, biomedical, pharmacist) or equivalent by expertise. PhD is an advantage
• At least 10 years of global clinical regulatory experience gained preferably at top-15 pharma companies or clinical research organizations (CROs)
• In depth knowledge of regulatory content and lifecycle management for CMC, Labeling, Safety, and other regulatory domain areas. In-depth hands-on expertise of regulatory processes, needs and challenges (e.g. submission strategy, planning & monitoring, content authoring, publishing & aggregate reporting, data anonymization, product labelling, regulatory intelligence collection & dissemination) and innovative trends in the regulatory domain at global level.
• Experience in one or more of the following RIM systems i.e., Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems or publishing tools.
• Hands-on expertise in F2F engagements with various Health Authorities for innovative technology solutions will be an advantage.
• Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. Transcelerate, IMI)
• Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language
• Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.

Language

· Fluent in English

· Native German, French, Dutch or Swiss language is an advantage

Travel

· Travel expectations around 10% max.

Location

· Other locations are also possible.

Job Type: Full-time

Pay: Up to $200,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Have your worked for any of the top 15 pharma companies?
• Do you have experience in one or more of the following RIM systems i.e., Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems or publishing tools ?

if so, please specify

• Do you have hands-on expertise in F2F engagements with various Health Authorities for innovative technology solutions ?

If yes, please specify what innovative technology solutions.

Education:

• Master's (Required)

Experience:

• Clinical Regulatory: 10 years (Required)
• Clinical research: 5 years (Required)

Willingness to travel:

• 25% (Required)

Work Location: Remote

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