Head of Regulatory Affairs
Company: ProClinical Ltd
Closing Date: 28 Oct 16
Salary (£): Competitive
This an exciting opportunity for a Head of Regulatory Affairs to join an innovative yet established global vaccines and biologics company based in Cambridge, Massachusetts.Responsibilities:
This role contributes to the vision and goals for Global Regulatory and ensures that the International Regions objectives are aligned with the strategic objectives of Global and US & Americas Commercial Group. ...
This an exciting opportunity for a Head of Regulatory Affairs to join an innovative yet established global vaccines and biologics company based in Cambridge, Massachusetts.
- This role contributes to the vision and goals for Global Regulatory and ensures that the International Regions objectives are aligned with the strategic objectives of Global and US & Americas Commercial Group.
- Provide leadership, strategic direction and managerial oversight to the US, Canada and LATAM based regulatory teams to develop and execute regulatory strategies and plans for the region. Interface with other function leads to ensure collaborative connectivity with these key stakeholders, and a focused regional regulatory approach to supporting country and regional business objectives.
- The Head of Region, US & Americas will be a direct report to the Global Head of Regulatory Affairs, with US and LATAM Regulatory team members as direct or indirect reports. The role will have direct responsibility for the Regulatory Affairs consultant support in Canada, and will direct strategy with respect to Canadian filings and the interactions with the BGTD.
- This role is the primary liaison for the company with the FDA, CBER and is responsible for establishing the regulatory credibility for the company, maintaining a relationship with the FDA that facilitates a constructive and collaborative dialogue that enables the timely delivery of regulatory outcomes consistent with the company strategy throughout all stages of the product lifecycle.
- This role will advise senior and executive management on the regulatory climate and proposed changes in FDA rules and regulations, policies and guidance's that could impact the business.
- A degree in Biological or Medical Science or Pharmacy, preferably with a post graduate qualification
- Biologics/Vaccines experience needed
- At least 10 years of regulatory experience, supported by additional pharmaceutical/industry experience
- Extensive experience at a senior level in Regulatory Affairs, with a strong knowledge of regulatory affairs legislation and processes in the US
- Demonstrated experience across drug development and commercialization lifecycle, with proven examples of contribution
- Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities with biological products
- General management experience with line management and leadership at senior management level is essential
- Demonstrable experience in establishing and building a high performing team essential, and specifically a RA team highly desirable
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.