Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Regulatory Affairs Specialist III

Expired Job

Planet Pharma Cambridge , MA 02138

Posted 3 days ago


Major Activities/Key Responsibilities

Responsibilities include:

  • Global Regulatory Team Lead for 30 INNs within the Established Products Group.

  • Develop the Global Regulatory Product Strategy (GRPS).

  • Interface with the development/project teams.

  • Represent the GRT at Regulatory Sr. Management Committees and other governance reviews.

  • Attend Health Authority (HA) meetings as required.

  • Lead and stimulate the Global Regulatory Team.

  • Develop the competitive target label and Company Core Data Sheet.

  • Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.

  • Liaise with HA contact person; organizing and preparing HA meeting and leading.

  • Accountable for keeping the databases updated on a timely basis for portfolio.

  • Provide support and communicating information on products to other functions (approvals, ).

  • Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies..

  • Manage post-submission activities (shortages, DHPC, B/R reevaluation, ).

  • Maintain professional working relationships with colleagues, fostering collaboration and idea sharing.

  • Advise management and team members of major regulatory issues and actively contribute to their management.


Experience/Professional Requirement:

  • Strong strategic skills including the ability to make complex decisions

  • Excellent operational skills including planning, organizing and ability to motivate and lead others.

  • Strong sensitivity for a multicultural/multinational environment

  • Knowledge about the Global Business Unit organizational structure, how business is driven (with financial understanding)

  • Knowledge about the discovery and development of pharmaceutical products, the role and importance of the RA function and how it fits into the development process

  • Knowledge about the Global regulatory environment including specialized Therapeutic areas as appropriate, the organizations involved and how legislation is developed

  • Experience with the current procedures for obtaining approval to carry out clinical trials at Global level (e.g. IND, CTAs, IMPDs and other supporting documentation) as well as on how best interact with regulatory bodies and HTAs for optimizing development strategy

  • Experience with registration procedures in major markets for MA approvals, variations, extensions and renewals and the importance of regulatory strategy to obtain the best possible outcome

  • Experience with the content and format of registration files (Common Technical Document and eCTD) as well as on how to best interact with regulatory bodies during the review processes



  • Bachelor's degree and at least 5 years in Regulatory Affairs or relevant industry experience

  • Master's, PharmD, PhD degree and 3 years in Regulatory Affairs or relevant industry experience

  • Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.

  • Regulatory Affairs Certification (RAC) Preferred

Type:Temp/ContractLocation:Cambridge, MA

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Regulatory Affairs Speciali...

Ra Pharmaceuticals

Posted 2 days ago

VIEW JOBS 7/14/2018 12:00:00 AM 2018-10-12T00:00 Description: Ra Pharma is seeking an experienced and energetic person to manage, evaluate, and complete regulatory submissions consistent with company goals. The successful candidate will be responsible for overseeing operational aspects of all regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget. The position will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners. RESPONSIBILITIES: Under direction from, and in collaboration with the Director, Regulatory Affairs, the candidate will: * Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad. * Manage document publishing for regulatory submissions from all areas of the company, in support of active INDs in eCTD format (formatting, publishing, submitting, life-cycling, and archiving sequences) such as clinical trial applications, IND/ODD annual reports, amendments; may include both paper and e-filings. * Manage outsourced publishing and records management vendors, as applicable. * Create and manage submission plans, in conjunction with Regulatory colleagues. * Represent Regulatory Affairs in project teams to support submission planning and ensure coordination of system development activities. * Reviews submission documents in accordance with the company's high standards as well as global regulatory standards. QUALIFICATIONS: The ideal candidate should have a minimum of 3-5 years overall regulatory experience in the pharmaceutical industry. The candidate must have a BA/BS degree or equivalent in a health science field. Experience and knowledge in preparation of INDs, and supportive amendments (manufacturing, nonclinical, clinical). Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communication skills are a must, as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment. To apply, Ra Pharmaceuticals Cambridge MA

Regulatory Affairs Specialist III

Expired Job

Planet Pharma