Associate Director, Regulatory Affairs

Salary: £180000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 530
Published: 27 days ago
The company

My client is a biopharmaceutical company who specialise in antiviral treatment. They are seeking an Associate Director, Regulatory Affairs to join their dynamic team. This is a full time permanent remote position.


The role

The Associate Director, Regulatory Affairs is responsible for contributing to innovative, breakthrough global regulatory strategies for product development and approval. With limited guidance from the Executive Director of Regulatory Affairs, the incumbent is responsible for providing procedural and planning support for submissions in countries outside of the United States.  The individual will have prior international regulatory experience and have worked on CTAs and/or MAAs.
 

Essential Duties and Responsibilities:

  • Plans and coordinates new submissions and dossier/packages per the product's global regulatory strategy to ensure timely submissions for CTA/INDs, NDA/MAAs, international Marketing Applications, Health Authority meetings, etc.
  • Collaborates closely with Clinical Operations and external clinical CRO to establish submission timelines and content of Modules
  • Draft Module 1 and program-specific components, and organize the gathering of documents for the entire submission working closely with internal stakeholders and external CROs.
  • Provides regulatory support during review of new submissions or variations, in order to ensure accuracy / consistency of content and that submissions are made according to regulatory requirements.
  • Monitor and analyze appropriate global regulatory agency activities in areas of interest to the company. Keeps up to date with procedural requirements and legislation. Assess impact on programs.
  • Identify and assess regulatory risks and define strategies to mitigate risks.
  • Provides support related to the development and implementation of global regulatory strategies.
  • Ensures updates to internal regulatory databases and participates in the development of internal operating procedures.
  • Participates as SME in relevant workstreams/projects as deemed appropriate by Regulatory Affairs Senior Staff.
  • Evaluates activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation
  • Applies / advises development teams on policies, procedures and applicable regulations /standards.

Qualifications (Education, Certifications and/or Experience)

  • University degree in a scientific/technical discipline with a minimum of four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
  • Must have experience in working on CTAs and/or MAAs.
  • Sound understanding of ICH and major markets' regulations.
  • Prior experience in pharmaceutical regulatory filings, approvals, and strategic planning.
  • Excellent written and verbal communication skills in English. Ability to communicate clearly and concisely with regulatory authorities and senior management.
  • Strong project management skills, including good interpersonal and organizational skills.
  • Proven ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.
  • Ability to effectively work in a team environment and develop peer relationships.
  • Demonstrates the ability to check regulatory documents to determine accuracy and find potential errors. Strong attention to detail.
  • Basic computer skills (MS Office, MS Teams, MS Excel, MS PowerPoint and Adobe Acrobat).  Experience with Veeva systems desired but not required.
  • Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
Connect

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.


Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything