Senior Regulatory Affairs Specialist

2 weeks ago

Makati City, National Capital Region, Philippines Lennor Metier Consulting Philippines Full time

Lennor Metier Consulting, a leading Recruitment Agency & Headhunters in the Philippines, is urgently recruiting a Senior Regulatory Affairs Specialist - Cosmeticsto join one of its fast-growing cosmetics client companies.

Salary Range: up to ₱60,000

Work Setup: Hybrid with 2-3x onsite a week.

Shift Schedule: Day Shift

Location: Makati, City

The salary offered depends on your skills, expertise, and evaluation results.

About The Role:

This role is crucial in ensuring that all products comply with regulatory standards set by the Food and Drug Administration (FDA) and other relevant authorities. You will be responsible for managing regulatory submissions, maintaining compliance documentation, and providing strategic guidance on regulatory matters.

Your Responsibilities:

Regulatory Compliance:

  • Ensure all company products are compliant with FDA regulations and safe for human use.
  • Secure necessary documents such as LTO, Business Permits, GMP Certificates, and Distribution Agreements.
  • Act as the primary liaison with the FDA.

Documentation and Submissions:

  • Prepare and review dossiers, facilitate submissions to the FDA, and ensure compliance with deficient requirements.
  • Monitor and follow up on submission statuses and secure approvals.
  • Maintain updated Product Information Files (PIF) for all notified products.
  • Immediately apply for initial product registrations, variations, and renewals with the FDA.
  • Ensure the validity of the company's License to Operate.

Product Development Support:

  • Curate validation reports to assist the Product Development Manager in maintaining product integrity.
  • Assist in creating comprehensive product decks for all new and existing products.

Cross-Functional Collaboration:

  • Coordinate closely with relevant departments to ensure compliance with FDA documentation requirements.
  • Participate in Sales & Marketing Planning processes.
  • Serve in cross-functional roles to support corporate objectives.

Industry Awareness:

  • Stay updated on the latest developments in the cosmetic industry.

What our Client is Looking For:

  • Bachelor's degree in a related field (e.g., Pharmacy, Biology, Chemistry, Chemical Engineering, Botany).
  • 1-2 years of experience in Food, FMCG, Medical Device, Pharmaceutical manufacturing, or a related industry.
  • Preferably trained or willing to undergo QPIRA Training for Cosmetics and Household Urban Hazardous Substances.
  • Proficiency in MS Office (Word, Excel, PowerPoint).
  • Excellent oral and written communication skills.
  • Strong initiative and good judgment.
  • Excellent planning and organizational skills, especially in handling policies, schedules, and workflows.
  • Agile, proactive, collaborative, and demonstrating leadership potential.
  • Resourceful and detail-oriented.

Ready to take the next step in your career? Submit your application now

- -

About Us

Lennor Metier Consulting is a top recruitment agency and Headhunters licensed by DOLE. We specialize in IT, Finance, Engineering, Sales & Marketing, Supply Chain, HR & Executive Search. With expertise spanning multiple industries, we leverage our extensive network and industry knowledge to connect leading organizations with top-tier talent, ensuring successful placements that drive business growth and success.

--- We kindly request your patience as we receive a significant number of applications. Rest assured that our team will update your application's status soon. In the meantime, we encourage you to follow our LinkedIn page to stay informed about future opportunities and company updates.

Job Type: Full-time

Pay: Up to Php60,000.00 per month

Schedule:

  • 8 hour shift
  • Day shift

Supplemental pay types:

  • 13th month salary

Application Question(s):

  • Can you start ASAP?
  • What is your current basic pay?
  • How much is your salary expectation?

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