Vice President – Regulatory Affairs

Job Type: contract
Job Category: Regulatory Affairs
Region: USA
Location: Unspecified
Posted: 21st May 2020
Ref: VPR0-100

Company Description

My client is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases.

Job Summary

The Vice President, Regulatory and Quality Assurance will join the executive management team and assist in the development and implementation of strategies, business plan, budget, and works plans to achieve company’s vision and mission. The position will provide leadership for all Regulatory and Quality activities to drive product development programs and ensure the Company’s ongoing compliance with regulatory mandates. Oversee the company’s regulatory activities and initiatives, assure the quality of products and processes, and ensure the highest integrity in regulatory and quality compliance. Will lead teams to strategize product development plans and advise department leaders of regulatory considerations in-light-of the Company’s goals and overseeing all aspects of submissions to regulatory authorities. Must be a dynamic leader with outstanding communication, strategic and collaboration skills, and will provide adept supportive leadership.

Specific Regulatory Responsibilities Include

    • Serve as the primary corporate interface for all regulatory authorities, both within and outside the U.S.
    • Identify required or advisable regulatory submissions, both within and outside the U.S. based on corporate objectives; establish timelines for preparing, reviewing, and finalizing submissions.
    • Develop document templates to assist individual functional groups with responsibility for drafting substantive content; coordinating with multiple groups to maintain submission timelines, providing final review to ensure internal consistency, satisfaction of regulatory requirements, corporate objective(s), and overall “fitness for purpose”.
    • Responsible for defining requirements for writing, editing, final review and approval of reports and regulatory submissions.
    • Accountable for the accuracy of regulatory submissions, and communications with Regulatory Agencies.
    • Participate in internal cross-functional group meetings and providing regulatory input in multiple areas, including clinical study design and endpoints; preclinical pharmacology and toxicology; and CMC.
    • Responsible for organizational policies and standards to maintain corporate regulatory compliance and maintains responsibility for the implementation of such policies and procedures.
    • Develop and implement a departmental budget that meets all corporate and regulatory goals and requirements.
    • Review Final Study Reports, manufacturing process documentation, Investigator Brochures, Clinical Study Protocols, and clinical trial documentation for compliance with cGCPs, cGMPs, cGLPs and other regulations and guidelines.
    • Communicate changing regulatory requirements with senior management throughout the company.
    • Stay current with regulatory developments relevant to the Company’s programs.
    • Advise senior management, including making recommendations regarding tactical and strategic considerations in the context of corporate goals and identifying changes and trends within regulatory bodies, both within and outside the U.S.
    • Establish a network of relationships with key national and international regulators/regulatory agencies; interacts with key scientific, clinical research, marketing and commercial personnel internally and externally to ensure timely and accurate regulatory compliance.
    • Defines and establishes regulatory strategies for product development efforts and works closely with research and clinical development.
    • Ensures that CMC and clinical trial protocols are properly designed to comply with current regulatory guidelines.
    • Accountable for timely adverse event reporting to regulatory activities.
    • Perform other duties as required.


Desired Knowledge And Abilities

    • Experience in all phases of regulatory submissions and interactions, including post-approval experience; international experience also required, along with direct contact and negotiation experience with the FDA.
    • Rare disease experience a plus.
    • Experience in leading the Quality function for a biopharmaceutical company and familiarity with GxPs.
    • Experience with electronic filing and database management abilities.
    • Experience with documentation systems and with document review and auditing.
    • Excellent communication skills, team member that can work collaboratively with colleagues across all functions.
    • Excellent analytical, presentation, writing, and computer skills are required.
    • Comprehensive knowledge of current US and ex-US regulatory guidelines.
    • Demonstrate excellent leadership and communication skills.
    • Demonstrate strong organizational skills, including the ability to prioritize personal workload.
    • Extensive supervisory experience and ability to guide, train, supervise and prioritize workload of direct reports.
    • Senior managerial experience in a small company environment is desirable.
    • Ability to work well in a deadline-driven environment.
    • Capable of supporting multiple projects simultaneously.


Education And Experience

  • Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
  • Minimum of 20 years of experience in pharmaceutical / biotech
  • Minimum 15 years in a management role within Regulatory / Quality Assurance

About Your Consultant

Email: Telephone: +1 646 415 8221

Alternative Job Search

Apply Now
We love nothing more than getting some glowing #feedback about one of our Consultants!

Congratulations Katherine…
0 2
Do you want to work for a company where you can directly influence our growth? We’re expanding our team at our Glob… 0 0
Intrigued what a day in the life of Talent Acquisition looks like?

In our latest blog, Lauren Tait talks about th…
0 0
Want to love your job and Monday’s again?? We’re currently hiring experienced recruiters, if this is you then get i… 1 0
Wishing all our followers a wonderful July 4th weekend 🇺🇸🗽🎇

#lifeatbj #barringtonjames #recruitment…
0 0
#TBT to this time last week that we had none other than @davidhasselhoff break the news that we are moving offices!… 1 0
Want to join a company and bill in a recession resistant sector?

Do you have 12 months + recruitment experience? I…
1 3
Ever wondered what a typical day in the Board & Executive team looks like? In our latest podcast we talk to Michell… 0 1
It’s PAY DAY LOTTERY time!!! Did you know that we take a percentage each month for our chosen charities? So far thi… 2 1
Here it is….our big announcement and who better to deliver it than The Hoff himself!

Check out all the details on…
2 3
Who fancies some exciting news?? Today is the day!

Stay tuned for our announcement later today!

0 0
Did you know we have big growth plans and are still hiring!?! It’s a special #wednesdaywelcome to the newest member… 1 0
Change is coming and we can’t wait to announce it...stay tuned to find out more!

#lifeatbj #barringtonjames…
0 0
Are you a 2020 Graduate looking to build a network in the most sort after industry across the globe? We have an opp… 0 2
Need a little motivation this Monday morning? Check out our latest blog from UKUS Recruiter, Theo Hillman, about re… 0 1
Roche’s Tecentriq plus chemotherapy meets primary endpoint in TNBC trial

#LifeatBJ #BarringtonJames #Chemotherapy…
0 0
Don’t they scrub up well!!!

Our virtual @RoyalAscot_MKT is in full swing, head over to our Insta stories to see w…
0 2
Cambridge AI firm says drug identified in April could have saved 5,000 lives

#LifeatBJ #BarringtonJames #Business…
0 1
Talking about and being open about mental health is so important, especially at the moment. A huge shout out to… 0 0
Takeda, Neurocrine sign $2bn deal on therapies for psychiatric disorders

#LifeatBJ #BarringtonJames #Takeda…
0 0
Congratulations to our latest qualifiers for our High Rollers Club 2020. Where are they heading??? Who knows, this… 0 0
Specialist CRO pharmaceutical services signs major new contract with a leading vaccine developer

0 0
Check out our latest blog to hear the views from Chris Tower a Senior Consultant in the QA space… 0 0
Vertex gets EC nod for Kalydeco to treat children with cystic fibrosis

#LifeatBJ #BarringtonJames #Vertex…
0 0

Load More

Spotlight on Lauren Tait, Talent Acquisition

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