Director of Regulatory
2 weeks ago
Our client is now hiring for Director of Regulatory for growing cosmetics and OTC manufacturer in New Jersey. This role will report the Chief Scientific Officer and will have management responsibilities in addition to overseeing regulatory of OTC and cosmetics products. This role has significant growth opportunity with vertical career trajectory with an established and growing manufacturer with multiple sites across the US. This role has significant autonomy and immediate impact on the success and growth of company. This position will be located on site in the Ridgefield office.
Responsibilities:
- Develop a strong understanding of the companys products, organization, business strategy and both its tactical and strategic objectives to plan and effectively manage its regulatory priorities.
- Directs and communicates complex regulatory issues at senior levels across the company and with external agencies and third parties in alignment with business needs.
- Develop and lead regulatory interactions with FDA and global regulatory/business strategies.
- Lead and/or support the preparation of submission packages for regulatory agencies principally in the US. Identify key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.
- Build and maintain strong, collaborative relationships with all key stakeholders and other functions key to the success of product development.
- Select and manage external resources involved in submissions and other potentially contracted regulatory activities.
- Develop and maintain a strong current knowledge of US regulatory requirements as they could potentially affect the companys regulatory strategy/timeline. Provide strategic guidance regarding developmental plans as a result.
- Support global product ingredient registration to the REACH portal and completing Annex 14 for China RM/formula registration.
- In charge of reviewing labels (*probably limited to ingredient list and fill weight unless defined the scope of responsibility upfront), testing and claim substantiations.
- Oversee the Register raw material through the COSMOS portal, NSF, WERCS, PCPC ingredients registration.
- Hire, train, and mentor regulatory staff as necessary to meet the companys business requirements.
- Responsible for continuing research and reporting of new or changing cosmetic regulations worldwide.
- Interface with Marketing, R&D and Planning regarding all ingredients and formula related regulatory requirements, issues and updates.
- Provide customer guidance regarding regulatory issues and updates.
Required Qualifications:
- Bachelors degree in related scientific field.
- 10 or more years of experience in Regulatory with OTC experience within manufacturing environment.
- Proven project leadership and team management experience with desire to mentor and develop teams.
- Excellent interpersonal and communication skills including strong presentation skills, evidencing the ability to effectively communicate across all levels of professionals both internally within the company and with external partners and regulatory authorities.
If you meet the required qualifications and are interested in this role, please apply today.
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About Solomon Page
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