Regulatory Affairs Sr Manager / Associate Director – Oncology – Global Role ** New Jersey **

Reference: SMR2309

Expiry Date: 10-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Mercer County
Съединени щати

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Job Description

My client is a well-known, household name, a top 20 R&D based Biotech company, with many successes under their umbrella and a wide and diverse pipeline which includes CAR-Ts, mAbs, NCEs, and ADCs in multiple therapeutic areas. They are looking for a Sr Manager or Associate Director to support a GRL in Clinical Development Regulatory Affairs, preparing INDs, Scientific Advice, Prime, Orbus and BLA / sBLA filings. You will assist the GRL in defining global regulatory strategies and major submissions, including NDA/BLA/MAA submissions for first submissions and new indications. The company have several high value brands in these therapy areas, as well as 6 NMEs in development, half in late phase.

Position Responsibilities:

  • In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across oncology.
  • Lead and/or support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
  • Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT.
  • Propose approaches to resolve regulatory issues and appropriately drive speed to patients.
  • Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities.
  • Lead the preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries.
  • Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP), etc.
  • Understanding of scientific content, drug development and regulatory requirements.
  • Participate in the assessment of regulatory precedence and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g., registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom.
  • Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops.
  • Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).
  • Facilitate identification of and internal agreement on target labeling.

Degree / Experience Requirements:

  • Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience.
  • At least 2-4 years of relevant regulatory experience or 4-8 years pharmaceutical industry experience.

Key Competency Requirements:

  • A basic knowledge of (i) drug development and (ii) policy, laws, regulations, and guidelines as they apply to the FDA for drug development and approval is required. Good interpersonal skills, willingness to leverage strengths of the team and cooperate with peers within in a cross-functional environment. Proven ability to work with outside partners.
  • Demonstrated ability to be solution-oriented.
  • Seeks multiple perspectives and listens openly to others’ points of views.
  • Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
  • Demonstrates ownership of results within (and beyond) area of responsibility.
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
  • Looks for opportunities for continuous improvement.

Other Qualifications:

  • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
  • Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
  • Demonstrates ownership of results within (and beyond) area of responsibility.
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
  • Looks for opportunities for continuous improvement.

Package & Relocation:

My client will buyout losses including stock and bonus, and they provide a decent package with a yearly stock plan which is RSUs, Share Options and a decent bonus plus they offer a full relocation package if needed from anywhere in the USA.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Roland Schnapka, for this role by email to Roland@advtalent.com or if you would like more information on the role, on US 908 348 6717. I will support you throughout the interview and on-boarding experience.

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