Location
Home Based
Position Id
1089

GeneCoda has been retained to identify and evaluate candidates, for a regulatory affairs client liaison.

About Our Client:

Our client, a leading provider of scientific and regulatory consulting services to Pharmaceutical clients, is a division of a global quality assurance services firm that provides customized qualification solutions to varied industries.

Narrative:

Our client’s emphasis is in preparing IND filings for small to mid-sized biotech and pharmaceutical companies, including electronic submissions. As such, our client’s work environment will appeal to professionals who enjoy varied client experiences including work in exciting new science like CRISPR and gene editing.

Our client seeks a Regulatory Affairs professional with a technical background in submissions (e.g. IND, NDA) that has a prior background in or affinity for client interaction and business development.

This hybrid role represents an opportunity to be both a Program Manager and contribute to our client’s business development efforts promoting the pharmaceutical consulting and e-publishing business. Therefore, this role represents the prospect of higher total earnings than otherwise might be found with a similar regulatory submissions focused role.

In this exciting role, the Regulatory Affairs candidate will use their project and submission management experience; work with a team of experienced regulatory affairs/operations subject matter experts; and leverage industry contacts to grow the regulatory affairs and e-publishing businesses.

Key Responsibilities:

  • Drive sales growth of the regulatory portfolio.
  • Identify new target customers and new opportunities within an existing customer base.
  • Deliver presentations, lead discussions and manage follow up.
  • Establish relationships with new and current clients.
  • Participate in conferences and client meetings.
  • Lead generation by attending conferences, targeting key customers and expanding contact base within accounts.
  • Author and review submission documents which might include IND’s, CTA’s or NDA’s.
  • Key account contact and acts as regulatory program manager for projects.
  • Work closely with and provide support to the VP of Pharmaceuticals & Healthcare and the Director of Regulatory Affairs.

Education: BA/BS degree or equivalent in a business or health related field, or equivalent combination of education and experience.

Experience and Qualifications:

  • 5+ years of regulatory affairs submissions experience required.
  • Experience working in the CRO or consulting pharmaceutical industry an advantage.
  • An effective networker with the ability to communicate and sell to clients of all levels, from bench scientist to VP level.
  • Prior experience in a Business Development position within Life Science selling into Biotech & Pharma, preferred.
  • RAC certification, preferred.

Desired Characteristics:

  • Excellent oral and written communication skills.
  • Well organized and structured (attention to detail).
  • Able to work independently and in teams.
  • Ability to deliver financial objectives.
  • Motivated to meet submission timelines.
  • Enjoys selling and is comfortable using negotiation skills.
  • Ability to work remotely (home based).
  • Estimated 30% travel required (post-Covid 19)

GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.

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