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Head of Regulatory Affairs

Cambridge, MA 02142

Posted: 01/17/2019 Job Category: Clinical: Regulatory Job Number: 2164

Reporting to the Head of Global Development / Chief Development Officer, the Head of Regulatory Affairs will lead the regulatory department to support the development, registration, and lifecycle management of our client' s products. The regulatory team is responsible for devising and implementing regulatory strategies, preparing and submitting regulatory documents, providing regulatory advice, and reviewing and approving external facing communications. The Head of Regulatory Affairs will ensure that programs are resourced with appropriate regulatory expertise to successfully implement regulatory strategies and business objectives. S/he will also lead development and implementation of department policies as well as maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs. S/he will continue to evolve the regulatory organization while providing oversight and mentoring to an established regulatory team. This team works well together with external global partners and other internal departments; therefore, we are looking for a like? minded regulatory scientist who values a collegial work environment and evidence-based strategies. The Head of Regulatory Affairs will not only play a major role in ensuring collaboration and strong relationships both internally with various departments, but also externally with regulatory agencies, business partners and vendors.

  • Overseeing the development and execution of global regulatory strategies in support of project objectives for Company products;
  • Keeping abreast of changes in the regulatory environment and adapting strategies appropriately;
  • Overseeing the planning and execution of meetings with health authorities;
  • Overseeing or providing regulatory due diligence assessments of new product
  • Providing review and commentary on regulatory documents;
  • Collaborates and ensures alignment with internal functions and external partners
  • Overseeing preparation and submission of global regulatory filings, including clinical trial authorization (e.g., IND, CTX) and marketing (e.g., NDA, MAA, IDL) applications as well as timely completion of routine regulatory submissions required for maintenance of applications, such as expedited safety reporting, annual reports, etc.
  • Directing and mentoring regulatory staff;
  • Overseeing regulatory review of external facing communications, including corporate communications, and investor relations;
  • Ensuring professional development of staff;
  • Overseeing development of timelines and budgets for department activities;
  • Providing appropriate resources (internal and or external) to ensure that the regulatory affairs function is capable of supporting the company’ s goals and
  • Overseeing the development of systems and procedures necessary to maximize the efficiency of the regulatory affairs department, and to comply with regulatory requirements; and,
  • Creating, modifying, and implementing regulatory infrastructure that enables the company to operate effectively and efficiently and support cross? functional communications and interactions.

  • B.S. degree in a health/life sciences field; advanced degree (e.g. M.S., Ph.D., Pharm.D., M.D.) preferred.
  • Minimum of 15 years of relevant experience (e.g. biotechnology, pharmaceutical industry, regulatory agency), with a minimum of 5 years in a senior leadership role managing a global regulatory function.
  • Broad experience across therapeutic areas, especially gastroenterology and rheumatology and significant experience in collaborations with partners.
  • Experience in global regulatory filings, especially in the US (IND/CTA, NDA/BLA/MAA), lifecycle management, leading interactions with Health Authorities, and developing and implementing complex regulatory strategies.
  • Experience in submitting at least two marketing authorizations and oversight of multiple commercial products.
  • Strong independent judgement; must be decisive, self? motivated and highly communicative as he/she will work collaboratively and effectively not only within the regulatory organization but across other disciplines to achieve shared objectives.
  • Strong strategic skills, including a demonstrated ability to make complex decisions and a willingness to defend difficult positions and demonstrates the ability to collaborate with internal and external partners.
  • Strong leader with proven track record in leading an organization through change and rapid growth and ensuring the appropriate capabilities are in place to support such growth.
  • Effective management, negotiation, and problem solving skills.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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