Genedrift

01/15/2026

I’ve been spending a lot of time reviewing applications lately, and it honestly breaks my heart a little. I see so many talented, hard-working freshers who are clearly 'the right fit,' but their applications never make it past the first gate because of small, avoidable mistakes.

If you're trying to break into Pharma or Regulatory Affairs right now, I want to pull back the curtain and show you how things actually work on this side of the desk.

I know how frustrating it feels. You’ve spent years studying Life Sciences, you’re ready to work, but every "Apply" button feels like sending your CV into a void.

Here is the honest truth about how hiring transitioned in 2025 and how it works today in 2026:

Most companies (including us!) use Applicant Tracking Systems (ATS). It’s not meant to be a barrier—it’s just how we manage the volume of incredible talent out there.
If you want to make sure your CV actually gets seen by a human, avoid these common traps:

❌ The "Interested" Comment on LinkedIn : Recruiters rarely have time to connect and DM everyone who comments. It’s the fastest way to be missed.

❌ Emailing directly: Unless asked, email usually bypasses the system that keeps your data organized for the right hiring manager.

❌ The "Generic" CV: If it’s poorly structured or missing keywords, the AI might not realize how qualified you actually are.

How to stand out and help us find you:
1. Use the Portal: Always apply through the official careers link. It puts you directly in the queue.

2. Optimize for AI & Humans: Use clear headings and industry terminology (e.g., "Quality Assurance," "Dossier Preparation," "Compliance").

3. The "Why" Matters: Even a 3-sentence cover note explaining your genuine interest in Regulatory Affairs goes a long way.

4. Submit in a Single Go - Upload CV, Cover Note and any other requirements together. Considering combining these as a single pdf (and do not submit CVs in jpg)

A final note to the freshers: If you don't hear back, please don't get disheartened. The transition from student to professional is a marathon, not a sprint. Persistence and attention to detail are the very traits that you need.

We are looking for fresh (and experienced) talent right now!
If you’re ready to start your journey, check our open roles here: 👉 https://www.genedrift.com/openings

01/13/2026

MAH Responsibilities Extend Beyond Filing

Holding a Marketing Authorization is not an administrative role—it is an operational responsibility.

Across multiple jurisdictions, MAHs are accountable for:

-> Ongoing pharmacovigilance compliance
-> Product quality oversight
-> Timely variations and renewals
-> Post-market reporting and audits

Misalignment between commercial teams and MAH obligations is a common source of regulatory risk.

Genedrift supports MAHs with structured governance models that ensure responsibilities are clearly assigned, documented, and executed throughout the product lifecycle.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

01/05/2026

In the new year, success will be defined by continuity—not just approvals.

Health Authorities increasingly focus on how products are maintained post-approval:

-> Timely safety reporting
-> Controlled variations
-> Ongoing GMP and PV oversight
-> Transparent authority engagement

Organizations that plan for lifecycle compliance early reduce disruption and protect long-term market presence.

At Genedrift, we design regulatory models that support continuity—from first approval through every renewal and inspection.

What We Offer (https://genedrift.com/what-we-offer
)
Contact Us (https://genedrift.com/contact
)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

01/02/2026

A new year brings new regulatory expectations.

Authorities across Africa and Asia continue to strengthen enforcement, expand post-market oversight, and raise expectations on data integrity and lifecycle compliance.

In this environment, regulatory affairs is no longer a support function—it is a strategic pillar for sustainable market access.

At Genedrift, we help organizations align their regulatory strategy with business goals—ensuring growth is supported by compliance, not constrained by it.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/31/2025

The future of regulatory affairs is proactive, not procedural.

As reliance frameworks, digital submissions, and post-market expectations evolve, the most successful organizations will be those that anticipate regulatory change rather than respond to it.

At Genedrift, we enter the new year focused on helping clients stay ahead—through regulatory intelligence, local expertise, and structured compliance systems.

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/29/2025

Before closing the year, it’s worth closing regulatory gaps.

Unresolved variations, incomplete PV documentation, pending renewals, and misaligned GMP records often carry forward unnoticed—until they become regulatory findings.

A structured year-end regulatory review helps organizations enter the new year with clarity, not compliance debt.

Genedrift supports all-year-round regulatory health checks across dossiers, PV systems, and quality documentation—ensuring a clean start to the year ahead.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/25/2025

Christmas is a season of trust, responsibility, and care (and some gifts 🎁)

In regulatory affairs, these values translate directly into how medicines and medical devices are governed—through accurate data, ethical reporting, and continuous safety oversight.

At a time when global supply chains are stretched and markets are interconnected, strong regulatory frameworks ensure that patient safety remains protected, regardless of geography.

At Genedrift, we support organizations in building compliance systems that reflect these principles—transparent, accountable, and patient-centric.

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/24/2025

As the year draws to a close, Christmas offers a moment to reflect.

For regulatory teams, reflection often reveals key questions:

-> Are our dossiers consistently up to date?
-> Are post-market obligations actively managed or only reviewed during audits?
-> Are regulatory risks identified early—or only after authority feedback?

Sustainable compliance is built through continuous attention, not year-end corrections.

At Genedrift, we help organizations move from reactive compliance to structured, year-round regulatory governance.

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/24/2025

Variations Management Is Where Compliance Is Tested

Initial approvals are visible. Variations reveal compliance maturity.

Label changes, manufacturing updates, supplier changes, and safety updates require disciplined variation management.
Inconsistent submissions or delayed notifications can jeopardize existing approvals.

Genedrift helps organizations design variation control frameworks that are auditable, timely, and aligned with local authority expectations—reducing regulatory risk over time.

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/22/2025

Regulatory Intelligence Is a Competitive Advantage

Why do some companies anticipate regulatory changes while others react too late?

Health Authorities across Africa and Asia are issuing frequent guideline updates—often without long transition periods. Companies relying only on published notices risk falling behind.

Effective regulatory intelligence means tracking draft guidelines, implementation signals, and enforcement trends—not just final notifications.

At Genedrift, regulatory intelligence is embedded into our consulting model, helping clients anticipate change and adjust strategy before it becomes a compliance issue.

12/18/2025

“Regulatory is not the real problem” (Contrarian consulting angle)

Most pharma companies don’t have a regulatory problem.
They have a translation problem.

The science team talks in mechanisms and pathways.
The regulatory team talks in guidelines and modules.
The commercial team talks in access and timelines.

And the dossier becomes a 10,000-page “PDF dump” instead of a coherent story.

The turning point for us:
We started every project with one slide:
“If I were the regulator, why would I say YES to this product?”

That single question forced:
• clearer benefit–risk framing
• better alignment between clinical, RA, and PV
• fewer last-minute document “rescue missions”

Most “complex” submissions became much simpler once everyone agreed on that one slide.

I’m seeing this pattern in almost every cross-border project we touch now.

Want to solve your challenges?

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....

12/16/2025

Cross-border approvals (Operational realism)

Our fastest multi-country approval didn’t come from a fancy new tool.
It came from deleting work.

We removed:
• duplicate trackers
• three overlapping status meetings
• and two separate “local vs global” planning docs

Instead, we kept only:
• one live ex*****on board (per market)
• one risk register owned by RA/PV together
• one person clearly accountable for “submission day readiness”

The result?
Fewer emails. Less drama.
And approvals that looked “magically” on time from the outside.

Teams don’t usually fail because they lack frameworks.
They fail because nobody is clearly owning the boring operational details.

This goes against the trend of adding more dashboards and tools—but it’s what actually works for us.

Want to solve your challenges?

What We Offer (https://genedrift.com/what-we-offer)
Contact Us (https://genedrift.com/contact)

Genedrift is a regulatory outsourcing enterprise working towards managing all activities relating to Regulatory Services for Pharmaceuticals. Operating in all segments - starting from Product Development, Quality Management Systems, Dossiers (CTD, ACTD & Regional Formats), Registrations, Strategy &....