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


Gilead signs $1.97bn worth collaboration deal with Arcus Biosciences

#LifeatBJ #BarringtonJames #Gilead…
0 0
#flashbackfriday to when @alex.zappulla won our Pay Day Lottery last month 🇺🇸💲💵💰🥂Who will be winning today?… 0 0
With the current situation and lock down giving us all time to reflect, we felt like now was a great time to re-vis… 1 1
FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent… 0 0
Our #HighRollersClub is the incentive to be on 🙌🏼 This December our qualifiers won’t know where they are going unti… 0 0
US FDA approves Takeda’s Alunbrig for rare and serious form of lung cancer

#LifeatBJ #BarringtonJames #FDA…
0 0
Sunovion gets FDA nod for Kynmobi to treat Parkinson’s disease off epis

#LifeatBJ #BarringtonJames #FDA #Sunovion…
0 0
On Memorial Day and always, we remember all the heroes who made the ultimate sacrifice

#LifeatBJ #BarringtonJames…
0 0
LYNPARZA approved in US for HRR gene-mutated metastatic castration-resistant prostate cancer

0 0
It’s important, not just now during #mentalhealthawarenessweek or these unprecedented times, to ALWAYS… 1 2
#TBT to when we could be together and celebrate the successes of 2019 and look forward to the coming year… 0 0
Novartis firm AveXis gets EC nod for Zolgensma to treat spinal muscular

#LifeatBJ #BarringtonJames #Novartis…
0 0
@BioPartner We are looking forward to partying properly, once it is safe to do so 0 0
EIGHTEEN! Today we celebrate turning 18!!! Check out our latest blog to read our story and watch how we still manag… 1 0
Deciphera gets FDA nod for Qinlock to treat fourth-line gastrointestinal stromal tumour

#LifeatBJ #BarringtonJames…
0 0
Head over to our Insta stories for today’s #tuesdaytalks to ask @domjwithers anything about his time at BJ, being p… 1 2
Congratulations to our winning team and MVP for our Lock Down World Cup Tournament #lifeatbj #barringtonjames… 1 0
Neuraptive Therapeutics announces FDA has granted fast track designation clinical development programme to treat pe… 0 0
NantKwest and ImmunityBio to initiate a phase 2 study of immunotherapy for metastatic pancreatic cancer

0 1
#flashbackfriday to when we virtually crowned our April Sales People of the Month. Congratulations to Dom 🇬🇧 Max 🇺🇸… 2 2

Load More

Our 2020 Vision – Are The Changes More Valued Now?

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.


Recruitment Resourcer – Horley, Surrey

Find Out More

Team Sales Manager – Experienced...

Barrington James is looking for an experienced recruiter to lead one of our teams in Raleigh and New York City.

Find Out More

Global Pharma – Freelance Clinical...

Freelance Clinical Project Manager - Denmark

Find Out More

Director, Business Development, Clinical...

My client a globally aligned top CRO – are seeking a Business Development professional with extensive...

Find Out More

Denmark – Freelance/Contract Senior...

Denmark Freelance/Contract Senior Clinical Research Associate 0.3 FTE

Find Out More

Sweden Clinical Consultant Needed –...

Clinical Consultant Immediately Required

Find Out More

Global CRO – London/Home Based –...

Alexander Antoniou is looking to find 3x Contract Statisticians to work for a Global CRO with their HQ based in...

Find Out More

Business Development Manager – EU...

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