Senior Regulatory CMC Manager – Pharma

Senior Regulatory CMC Manager - Pharma

Job Type: permanent
Region: Europe
Area: Switzerland
Location: Switzerland
Salary: Competitive
Posted: 25th June 2019

Scope of Responsibilities:
This person will work with the Director, Regulatory Affairs very closely and be a member of
multifunctional teams (company internal team members and third party CMO’s). They will provide
support for the needs of the Company from a regulatory point of view to ensure successful applications
with health agencies in the most efficient way. The individual may execute tasks like editing Module 3
sections and play a consultative role when choosing third parties by partnering across business

Specific responsibilities:
• Responsible for the timely completion of well organized, scientifically sound regulatory CMC
submissions, to include agency meeting packages, DMFs, INDs, CTXs, NDAs and MAAs,
amendments and supplements, responses to requests for information, etc. Writing of
Module 3 sections/participation in submission preparation is expected.
• Maintains an in depth level of understanding of the assigned compounds, their
characteristics, manufacturing aspects and specifications/analytical methods
• Reviews technical reports and summary documents (chemistry, manufacturing and quality)
for adherence to regulatory guidelines, strategies, and commitments.
• Contributes to writing expert summaries of CMC submissions
• Leads third party CMC teams on task forces as needed
• Leads RA review of Change Controls and co-ordinates with QA to ensure successful
• Leads preparation for CMC meetings with Health Authorities
• Maintains an understanding and awareness of existing and forthcoming legislation and
guidelines related to CMC.
• Provides regulatory expertise and policy support for GMP and represents the RA team as
CMC expertise on project teams

Work Experience/Education:
• Minimum of 5 years pharmaceutical/biotech industry experience in CMC Regulatory Affairs with
at least 10 years in the pharmaceutical industry in a technical compliance role of which 5 years
working with FDA/EMA related projects.
• Bachelor’s degree in scientific discipline preferred, or comparable experience.

Functional/Technical Knowledge & Skills:
• Strategic thinker, planner, and implementer. Excellent organizational skills.
• Excellent communication skills, knows how to present data/issues both to a technical and nontechnical audience
• Able to plan and execute regulatory projects, and proven record of delivering results within
business-defined timeframes.
• Sound knowledge of FDA/ EMA regulations and guidelines in the CMC arena, including GMP.
Knowledge of requirements in other regions is of advantage.
• Ability to write and edit technical documents
• Proven ability to work on complex problems where analysis of the situation or data requires an
evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and independent thought.
• Candidate must be fluent in English (verbal and written)
• Proficient in Microsoft Outlook, Word & Excel

For more information:

+44(0)1293 776644


It’s Friday which can only mean one thing... #BeerFridgeFriday‼️ The Barrington Arms is fully stocked and ready to… 0 2
#TBT to our last fundraising day for #thebritishheartfoundation and celebrating that the football season was back!… 2 1
#WednesdayWinners Congratulations to our Sales Person of the Month from our UK, USA & Asia offices🙌🏼🏆 #lifeatbj… 0 5
Our company will be attending @elonuniversity career fair in #NC area! Stop by to speak with our consultants to lea… 1 0
Our UK, USA & ASIA teams came together this week to get involved with @su2c @su2cuk #kisscancergoodbye campaign💋✨… 2 1
Throwback to when we took our UK shareholders to celebrate their achievements #lifeatbj #barringtonjames… 1 8
Last week the girl & guys in the red ties took over the Times Square Bar at NYNY in Vegas whilst attending the… 0 0
@hopscotchfest is finally here! A huge celebration of the best indie artists around 🥳 🎉 💃

Below is footage of our…
0 1
#ThrowbackThursday to our world foamous Ibiza Summer Party.

The stakes are raised next year as we’re planning pin…
4 8
Over 50,000 views of our summer party video already. We'd like to take a moment to thank each and every one of our… 1 8
Logging on to twitter and reading the online reaction to the summer party 👀

#LifeAtBJ #MondayMood…
2 6
Barrington James’ big dog Phill Davis celebrated billing his second million pounds for the company,by shopping for… 0 2
After you have prepared for the Apocalypse by stockpiling tinned goods and Mad Max DVDs, look for a career change h… 1 4
Our Summer Party definitely lived up to the hype!🌞 🎉

An open bar, *so* much food, a bouncy castle, in-house DJ, i…
3 7
Congratulations to Zac for completing his first deal within his first week in the company!

Unbelievable scenes. Un…
4 11
RT @AlzResearchUK: “A lady came up to us at the beach and asked if we could help fulfil her husband’s wish to ride a wave one last time bec… 192 0
RT @wellbeing_co: Today is #PositiveTwitterDay - just be kind to everyone you meet! We are all struggling with our own silent battles so be… 113 0
Our #PositiveTwitterDay message is to look for the best in people. It's what we do on a daily basis.

“You can’t ma…
1 2
#Throwback to our Summer Party last week!

The foam machine went down an absolute treat. A huge fan favourite.

1 3
A true hero of our times. The biggest single since Queen released Bohemian Rhapsody in 1975.

Think you could thriv…
3 6
All managers are off desk again today for more Leadership & Management training.

This can only mean one thing. Th…
1 5
The ‘before’ pics to our amazing BJ Ibiza #SummerParty🌞🍻

It was incredible and everyone had a great time with the…
1 5
Today some of our future leaders have come together for Leadership & Management training.

We believe in delivering…
2 6
That #FridayFeeling is certainly here! 44 minutes until the Summer party kicks off... 0 0

Load More

Anticipate – regard as probable; expect or predict.

Read More
Money Raised For Charity



Flags Earned last year 32
Conferences visited last year 49


We’re great at what we do. A collection of the world's finest Life Science recruiters working for the world's best Life Science consultancy.

We take time to understand your current situation and more importantly, your future needs - regardless of your location, specialism or market.


Trainee Recruitment Consultant Raleigh NC

I am looking for competitive, resilient people to develop their career in sales with us. If you want to earn a...

Find Out More

Trainee Recruitment Consultant (YR1 OTE...

Barrington James is an award winning recruitment consultancy. We offer our staff uncapped earnings with a Year...

Find Out More

Deutschsprachige/r Personalberater/in fuer...

Recruitment Consultant/ Frankfurt/ 6 month training based in London

Find Out More

Internal Recruitment Consultant-Uncapped...

Barrington James are an award winning Recruitment consultancy and we are growing fast! I'm looking for a brand...

Find Out More

Recruitment Consultant | Frankfurt | UK...

Work for a Top 10 Recruitment company

Find Out More

Head of Business Development / Business...

Barrington James are now looking for a Business Development Manager / Head of Business Development to support...

Find Out More

Recruitment Resourcer – Horley, Surrey

Find Out More

CRA Manager – Spain – Small...

I’m currently partnering a small to medium sized Pharmaceutical Company based in Spain looking for...

Find Out More

A Global Recruiter for the 21st Century

With offices across three continents, a member of the Barrington James team is always on hand to answer your enquiry, any time of the day or night. A truly global staffing solution for today’s modern professional.

See Our Locations

[Contingency Recruitment]

A no win, no fee service. Expect, as we do, that Barrington James performance will be outstanding in the speed of turn round of assignments, the quality of communication the client receives on the process and the standard of candidates presented.

Find out More

[Board And Executive Search]

A first-rate executive search team whose job it is to keep a close eye on scarce candidate communities. Specilaising in key appointments and board level hires. Experts in creating the right market strategy to fit specific client recruitment need, no matter sensitive, or specialist, or important.

Find out More

[Contract And Interim]

A dedicated Contracts Team of vertical market specialists who only network with freelancers. All jobs are fully qualified at the initial stage, with time bound deliverables agreed. All candidates are pre-screened and references checked.

Find out More

[Retained Campaign Management]

A true blend of services, enabling our teams to deploy a range of proven techniques and expertise to meet the clients’ particular requirements. Typically using strategic advertising, networking and social media, as well as database mining and selective headhunting.

Find out More