Regulatory Affairs Associate

5 days ago

Irvine, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for several products.

  • With supervision, the specialist reviews, plans and prepares regulatory documents and labelling for cosmetic or OTC product registrations/updates.

  • With supervision, the specialist researches and interprets health authority regulations/guidance and provides regulatory information to cross-functional teams, as appropriate.

  • Reviews product labeling for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to operations, medical affairs and commercial teams.

  • Provides regulatory guidance to other departments as needed to ensure compliance with regulations

  • Conducts regulatory assessments of product changes, labeling revision, and new product introduction.

  • Generates ingredient list (IL), Quantitative & Qualitative (Q&Q), and Cosmetic or OTC formulation assessments.

  • Reviews and approves formulations and labeling for local and global compliance.

  • Generates Origin, Animal testing, Allergens, CMR/Nano, Gluten Free, BSE and other requested statements upon review of formula or ingredients.

  • Acquires necessary regulatory documentation from Raw Material suppliers.

  • Provides insight to formulators to create global and local compliant formulations.

  • Prepares and submits regulatory documents for cosmetic registration and responds to other regulatory questions as needed.

  • Ensures archiving of activities, especially submissions, internal memos and key correspondence.

  • Monitors and interpret regulatory requirements and guidelines and assesses impact on SkinMedica products.

  • Notifies relevant cross-functional team members of regulatory activities, as appropriate.

  • Provides status updates to management.

Qualifications:

  • BS degree in a scientific field + 2 years' experience in regulatory affairs; or equivalent relevant work experience; OR

  • MS degree in a scientific field + 1 year experience in regulatory affairs; or equivalent relevant work experience; OR

  • PhD degree in a scientific field, with no experience in regulatory affairs.

  • Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.

  • Ability to manage multiple priorities and projects with strict deadlines

  • Detail-oriented with the ability to proofread and check documents for accuracy and consistency.

  • Excellent communication skills

  • Basic knowledge of personal care product industry regulatory affairs discipline throughout the product lifecycle including development, commercialization and operations.

  • Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.

  • Ability to manage multiple priorities and projects with strict deadlines

  • Working knowledge of the OTC drug monographs and cosmetics.

  • Detail-oriented with the ability to proofread and check documents for accuracy and consistency.

  • Excellent communication skills.

  • Strong interpersonal skills with the ability to influence others in a positive and effective manner.

  • Ability to understand and apply business drivers outside of Regulatory Affairs.

  • Submissions experience

  • Skincare background would be helpful, but not required

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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