Associate Director, Regulatory and Quality - Australia

Regulatory Melbourne, Australia


Description

 

 

Position: Associate Director, Regulatory Affairs - Australia/New Zealand

Reports to: Chief Commercial Officer (with dotted-line reporting to Regulatory Affairs)

Location: Australia

Position Summary
Apellis is looking for an experienced and capable Regulatory strategist to support growth and filings in Australia and New Zealand for Apellis. Management of the day to day activities including analysis of local Australian and New Zealand regulatory issues, providing region-specific input into global regulatory strategy, communicating with regulatory bodies, and ensuring quality requirements are met.  This individual will work closely with the Global Regulatory Lead for the assigned program(s) to ensure clear, consistent, and accurate regional regulatory guidance is provided to project teams and that regulatory deliverables are of consistent high quality and meet agency requirements and guidelines.


Key Responsibilities Include:

  • Manage, review, and organize documents intended for regulatory submissions.  Act as a liaison with global project teams to accomplish specific regional regulatory deliverables (eg, agency meeting briefing materials, orphan designation applications, marketing applications).  Work with the Global Regulatory Lead and other members of the Global Regulatory Team to achieve stakeholder alignment while meeting quality and timeline goals.
  • Interact directly with regional regulatory authorities to facilitate agency meetings and manage regulatory submissions.
  • Lead process for adaptation of global marketing authorization dossier into regional format, prepare locally required information, and submit for regulatory agency review.  Coordinate preparation and submission of responses to questions/information requests during the review process.
  • Prepare and submit post-approval information to regulatory authorities, including routine maintenance reports and requests for post-authorisation changes.
  • Based on initial or revised core data sheets, prepare regional prescribing information (PI) and product labelling, submit to regulatory authorities, and facilitate review/negotiation process. 
  • Track post-authorisation commitments and maintain records of regulatory interactions and submissions in applicable Apellis regulatory information management systems.
  • Collaborate with development or commercialization partners as required.
  • Monitor emerging trends regarding industry regulations and maintain awareness of evolving regulatory requirements or developments that pertain to Apellis products. Communicate and provide guidance to teams on any regulatory changes to assure continued compliance.
  • Conduct proactive gap analyses and regulatory risk assessments.  Develop and recommend mitigation strategies to ensure that program activities are appropriately designed and implemented to meet applicable regional regulatory requirements.
  • Identify and respond appropriately to regulatory issues by analyzing the challenge and providing adequate and innovative solutions.
  • Provide support and complete assigned tasks as outlined by Global Quality as applicable and requested.
  • Perform other duties as required.


Education, Registration & Certification:

  • University degree in a scientific discipline; graduate degree preferred.


 

Experience:

  • At least 8 years relevant experience in the biotechnology and/or pharmaceutical industry working on innovator drugs and/or biologics. Experience in registration of rare disease and/or hematology products desired.
  • Experience with combination products (drug + delivery device) is preferable.

 

Skills, Knowledge & Abilities:

  • Working knowledge of TGA and MEDSAFE regulations, and relevant policies, procedures, and guidelines.
  • Capability to quickly analyse problems, communicate options and take appropriate action for resolution. Ability to make timely and appropriate decisions as related to their area that are in-line with the function. Demonstrates consistent judgement under usual business conditions; makes sound recommendations in areas of uncertainty. Involves others in decision-making process as appropriate. Demonstrates capability for global business thinking in therapeutic area(s).
  • Effective planning and project management of multiple projects.
  • Comfortable working independently with supervision. Involves others in decision-making process as appropriate.
  • Highly organized, results driven, problem solver.
  • Superior written and oral communication skills and the ability to work with different levels of management. 
  • Highly motivated with the ability to be flexible in a fast-paced environment. 
  • Knowledge and background in Quality Assurance is desired.


 

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

Expected travel to the Company’s headquarters in Massachusetts, US. Additional travel as required for regulatory agency meetings.

 

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

 

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.