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Regulatory Affairs Associate Director or Senior Manager Job Opening In Lima Metropolitana – Now Hiring Dennis Partners

Regulatory Affairs Associate Director or Senior Manager

    Peru Jobs Expertini Expertini › Peru › Jobs › Lima Metropolitana › Gestión Y Operaciones › Regulatory Affairs Associate Director Or Senior Manager

Job description

Regulatory Affairs Associate Director or Senior Manager

This biopharmaceutical company is acquiring, developing, and commercializing innovative therapies for patients with rare diseases.

They are seeking an Associate Director of Regulatory Affairs (or Senior Manager) to manage day-to-day Global Regulatory activities for development and commercial pharmaceutical programs.

Reporting into the VP of Regulatory & Quality, you will support global regulatory strategy implementation and prepare regulatory submissions.

This company offers hybrid work arrangements, excellent employee benefits, and a tight-knit company culture.

With two approved products and another application currently under Priority Review by FDA, now is an exciting time to join this growing organization!

Base pay range

$130,000.00/yr - $200,000.00/yr

Responsibilities

  • Support global regulatory strategy and manage activities for a portfolio of Rare Disease programs.

  • Respond to FDA queries and support Health Authority interactions.

  • Support the compilation, review and/or filing, and maintenance of regulatory applications for US, EU, GB, and other applicable territories.

  • Coordinate and/or contribute by authoring and reviewing submission documents such as DSURs, PADERs, PBRERs, annual reports, variations, supplements and amendments as needed.

  • Maintain all regulatory logs (filings, communications, submission calendars, etc.).

  • Maintain applicable Regulatory licenses (U.S. State licenses, manufacturing, and distribution, etc.).

  • Develop and manage project timelines for regulatory submissions.

  • Coordinate with all internal and external contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission.

  • Implement or maintain regulatory affairs policies and procedures to ensure regulatory compliance.

  • Tracks submissions, correspondence, and commitments with regulatory agencies.

  • Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.

  • Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality, and meets eCTD submission requirements.

  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies and to ensure that appropriate regulatory agency requirements are met.

  • Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities.

Qualifications

  • Bachelor degree in a scientific discipline.

    Advanced degree (MS, PharmD or PhD) preferred.

  • Six or more years in Regulatory Affairs roles in a commercial biotech/pharmaceutical setting.

  • Strong knowledge of regulations/guidelines governing development of pharmaceuticals.

  • Knowledge and understanding of FDA and EMA regulations.

  • Experience and in the preparation of regulatory submissions, including INDs, NDAs, MAAs, etc.

  • Experience working directly with FDA and international regulatory agencies a plus.

  • Ability to work both independently with direction and within project teams and see all projects through to their completion.

  • Prior Regulatory experience with Rare Disease programs a plus but not required.

  • Regulatory Affairs Certification (RAC) preferred but not required.

  • Experience with hosting Regulatory inspections preferred.

  • Experience with taking the lead on complex projects and processes.

  • Excellent written and oral communication skills.

  • Strong organizational skills, including the ability to prioritize workload.

  • Strong interpersonal skills and the ability to deal effectively with internal and external collaborators.

  • Ability to meet deadlines and perform multiple tasks in a fast-paced setting.

  • Must be self-motivated and unafraid of challenges.

  • Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.

This is a hybrid position in the Greater San Diego area, and applicants must be in the office three days per week.

 Our client can provide relocation support for the right candidate.

Please note that our client is not able to support H1B or TN transfers.

Position details

  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Required Skill Profession

Gestión Y Operaciones


  • Job Details

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Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide


Real-time Regulatory Affairs Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Regulatory Affairs in Lima Metropolitana, Peru, highlighting market share and opportunities for professionals in Regulatory Affairs roles.

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The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Dennis Partners adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying Peru laws and regulations

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