Regional CMC Regulatory Leader Oligonucleotides at Senior Manager level (code USA 12-19-3)

Reference: DG10501

Expiry Date: 20-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

Regional CMC Regulatory Leader Oligonucleotides at Senior Manager level

Are you an experienced Regulatory CMC professional who is willing to work in the rapidly growing field of Oligonucleotides? Are you ready to take on a leadership role in a fast-paced matrix environment?  Then this CMC RRL vacancy is definitely for you!

What is the company like?

You will be joining an innovative biotech, where you will have the chance to work with some of the brightest minds in the field on cutting-edge programs just like in a startup, with the major difference that all projects are very well funded and organized.

They have been awarded for the way they take care of their people and help them grow to the next step in their careers. The company culture relies on transparency and holistic approach, where every individual is encouraged to bounce ideas with colleagues and expand their knowledge by getting involved in different projects and other areas of the business.

Employees tend to stay for many years with the company and besides generous remuneration, everyone is provided with great variety of opportunities to diversify their expertise and learn new things. Big deal of this success is achieved thanks to the efforts of leadership team, which has remained consistent over the years and operates with well-established synergy. You will definitely enjoy working with, and learning from, these people, who lead not by authority, but by setting a good personal example and by achieving consensus in any situation.

What is the job like?

Dynamic and highly satisfying is the short answer!

As a Regional Regulatory CMC Leader you will take ownership over the strategic and operational aspects of Regulatory CMC activities for your assigned project(s) and lead on the Regulatory CMC submissions all the way from early development to the first successful MAA.

You will be collaborating with cross-functional teams all around the globe to author, compile and review IMPD/INDs and author CMC content in Module 3 for NDA/MAAs, as well as writing and reviewing responses to Health Agencies in your region and worldwide.

Besides fulfilling the standard technical requirements related to RACMC, you will also become the main point of contact for affiliates and lead on the interactions with Health Authorities in your assigned region. You will regularly communicate with variety of stakeholders and influence the CMC Regulatory strategy, even more you will be leading its implementation as a Project Manager with the help of your assigned sub-teams.

How can I apply?

Before you apply, please make sure you have the relevant experience to become the next CMC Regional Regulatory Leader:

  • Minimum 5 years in Regulatory CMC where you have authored, compiled and reviewed IMPD/IND and authored into Module 3 of NDA/MAA;
  • Proven track record in managing projects and cross-functional matrix teams
  • Great communication skills and strategic thinking
  • Background in Small molecule or Oligonucleotides development.

I look forward to introducing to you the company and the position in greater detail and I will gladly address any questions you would have. Please send through an updated version of your resume along with your contact details and let us arrange a brief phone call to discuss this great opportunity!

To Apply!

To apply for this role, please press the red “Apply for position”, or contact me, Matt Greig, on 855.505.1382 to find out more about the role.

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