Director, Global Regulatory Operations

Regulatory Affairs Waltham, Massachusetts


Description

Description:

The Director of Global Regulatory Operations will play a critical and leading role in establishing internal publishing and operations capabilities. The successful candidate will provide oversight to effectively support timely and quality submissions for multiple indications performed internally and externally to ensure compliance to all global regulatory authorities and all aspects of electronic submissions and documentation that meet regulatory agency submission standards and technical requirements. He/She will oversee and coordinate the content finalization and review within cross-functional teams and subject matter experts, compile, prepare and review the various documents for content completeness and compliance with all the regulatory reporting requirements and publishing. 

Primary Responsibilities:

  • Maintains current regulatory knowledge of submission requirements, content, format and publishing for submissions to global regulatory authorities, instructs the team of changes to process and implements appropriate regulatory strategies to mitigate risks
  • Ensure submissions and related documentation are prepared in compliance with various global health agency regulations and guidelines and for regulatory application types including INDs, NDAs/BLAs, MAAs, JNDA, NDS and any related amendments/supplements.
  • Maintains expertise in publishing best practices and manages relationships with vendors in the evaluation and implementation of regulatory submission processes, systems and software
  • Works independently with program and project teams to design and execute high quality submission plans, ensuring that timelines and technical requirements are mutually understood and in line with current standards
  • Defines and implements standards and process efficiencies for submission management including drafting and adherence of SOPs and work instructions; ensures application of best practices standards are understood and followed by applicable departments/stakeholders and vendors
  • Operates as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory staff and representatives from cross-functional teams
  • Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with regulatory authority requirements and company standards. Acts as direct liaison with contributing departments to facilitate effective management of submissions.
  • Oversees development and implementation of standards for publishing and submission process by assuring completeness and quality submissions from operational perspective and identifying solutions for global regulatory submissions.
  • Oversees compliant archiving of all regulatory documents and global regulatory correspondence, including developing archiving system and processes for regulating access to archives and overseeing maintenance of all correspondence logs.

 

Key Skills and Competencies:

  • A well-organized self-starter who shows strong initiative and drive, establishes priorities, able to anticipate departmental needs and develops templates, processes and procedures to ensure compliance with regulations
  • Able to prepare interpretative analyses of key regulatory guidance documents related to submissions; interpret them, develop and implement submission strategies (from operations perspective)
  • Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in regulatory operations submission timelines.
  • Must be able and willing to work in a high-visibility, fast- paced environment • Must be flexible and able to work successfully within a cross-functional team
  • Excellent analytical and independent problem-solving skills
  • Able to Develop proposals for continuous improvement of internal systems and processes related to publication, submissions, and archiving of regulatory dossiers

Qualifications:

  • Bachelor’s degree (advanced degree preferred) in a life science field (Biology, Chemistry, or Pharmaceutical sciences)
  • 12+ years’ experience in pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience)
  • 10+ years Regulatory Affairs experience in drug development and product registration activities.
  • Demonstrated expert knowledge of regulatory submission including NDA, IND, IDE, MAA, CTA, CTD, NDS, CTN, JNDA, ACTD submissions and technological advancement on global authority guidelines & current regulations in drugs, medical devices and combination products.
  • Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external customer groups.
  • Knowledgeable in CTD/eCTD structure and requirements and US submissions (e.g. IND, DMF, NDA, PSUR etc.), a solid understanding of international submission requirements for multiple-countries in all applicable global regions such as Europe, Asia Pacific and other regulatory authorities.
  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and viewing tools.
  • Able to travel domestically and International with little 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.