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Head of Regulatory Affairs (Science & Biotech)
Greater Atlanta Area, GA 30075
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Dec 09, 2020
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Job Description

DESCRIPTION
Specialty pharmaceutical company focused
on providing therapies to patients with unmet medical needs. Addressing the needs of
patients with rare diseases and underserved neurological conditions are our passion
and focus. Supporting patients with high unmet needs by offering promising
treatment options is what drives us. Our seasoned management team has a broad
range of experience in commercialization, acquisition, licensing, formulation and product
development. We are a dedicated group of professionals who have committed our life’s
work to developing and bringing high-value, much-needed drugs to market. We are
looking for highly-skilled individuals who are patient focused, passionate, ethical, team oriented, and who want to help build a company that will make a difference in people’s
lives.

Location - Greater Atlanta, Georgia, global travel 20%

Reports to - Senior Vice President, Technical Operations

Role Overview - The head of regulatory affairs l will have primary responsibility for the oversight and
management of Regulatory matters related to the company's commercial and development
product pipeline globally. In conjunction with that, this leader will be responsible for
the establishment and monitoring of budgets and timelines, will coordinate closely with
other cross-functional development team members, and will provide technical guidance
and managerial oversight of the Regulatory team.

Responsibilities
• Provide the leadership on regulatory strategy and tactics contributing to the
achievement of business objectives.
• Provide Regulatory direction related to registration requirements for development
and commercially marketed products globally.
• Insure Regulatory support for development projects, project teams, and all
regulatory submissions (PIND/IND/CTA).
• Maintenance of registrations and insuring regulatory compliance for commercially marketed products.
• Responsible for insuring the regulatory review, evaluation, and recommendations
related to change controls/change requests for commercially marketed
products.
• Establish relationships with distribution partners, commercial
manufacturing partners, and other key stakeholders, providing regulatory
guidance and support as required.
• Lead the regulatory team to insure prioritized objectives are successfully
delivered; team management and performance responsibilities.

• Support other cross functional groups as required, to assist in the achievement of
business objectives.

• Maintain and utilize a strong working knowledge of regulatory requirements in
commercially relevant geographies.

• Provide Regulatory review/oversight/guidance for advertising and promotion;
regulatory review and submission process.

• Oversee activities relating to planning and execution of all regulatory
submissions.

• Develop/review and insure adherence to SOPs as required to support regulatory
compliance with FDA and all other relevant regulatory bodies.

• Provide inputs/recommendations and manage departmental Regulatory budget.

• Lead Regulatory Authority communications/interactions.

• Insure support and recommend process improvements for internal regulatory
documentation/tracking/archival systems.

• Provide support for Regulatory Agency inspections, as required.
• Lead Regulatory planning/requirements/ preparation/submissions related to
Regulatory Authority meetings, as required.

• Support for due diligence/business development opportunity evaluations as
required.
• Perform other responsibilities as may be required, consistent with a
growing, dynamic company.

• Domestic and international travel as required to establish/support vendor/ partner
relationships to maximize the success of the programs (approx. 20%).

Qualifications
• Bachelor’s degree in a technical field with a graduate degree preferred.
• 10 years+ regulatory experience in pharmaceutical, biotech or specialty pharma
companies. US/Canada experience required, ROW experience preferred.
• Experience with pharmaceuticals and biologics preferred; medical device
experience in addition a plus.
• Successful track record of building constructive relationships with all
stakeholders and team members including management, peer-group, and cross
– functional team members/reports.
• Proven influencing skills with internal and external stakeholders.
• Excellent oral and written communication skills.
• Experience in drug development (experience with drugs and biologics expected,
devices a plus).
• Knowledge and direct experience with the regulatory submissions process, in
particular electronic submissions.
• Demonstrated negotiation skills.
• Highly effective interpersonal skills and the ability to continually demonstrate
poise, tact, and diplomacy.

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