Senior RA Manager
Are you excited to lead US regulatory function for a fast-growing OTC and Medical Device business? If so, Global Regulatory Affairs Senior Manager, could be an ideal role for you! As Global Regulatory Affairs Senior Manager of Health and Wellbeing, you will be responsible to lead end-to-end regulatory support for US to create, grow and protect the business.
This role will provide YOU the opportunity to work with fast-pace business to progress YOUR career. Some of the responsibilities are as follows:
- Lead US OTC and Medical device regulatory function and partner with business to drive growth ambition.
- Manage and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans.
- Participate in external policy and advocacy to create, grow and protect the business. Represent company on appropriate forums.
- Develop and execute robust end to end regulatory strategy to support innovation and compliance.
- Partner with other functions like quality, supply chain to ensure timely regulatory deliveries.
- Work with external companies to ensure appropriate regulatory framework is in place to ensure end to end regulatory compliance (e.g. CGMP, labeling, advertisement, sales & distribution, claim etc.) for the business
- Work with in-house and external legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection
- Manage the pre-market registration or notification process to enable product sale.
- Provide regulatory guidance, risk assessment, and management throughout the product lifecycle: New Product Development and Commercial projects
- Maintains an open channel for communication between various stakeholders.
- Maintain specialized product category knowledge.
- Perform management tasks for the team. These duties include conducting reviews, maintain team motivation and dividing the workload among members of the team.
Skills and Requirements:
- Master's degree in regulatory affairs, science, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required.
- 12+ years of direct US OTC, Medical Device and Consumer Healthcare regulatory experience.
- Extensive knowledge of the Health Supplement regulation of Singapore and SEA countries. Additionally, US and EU preferred.
- Knowledge and experience on FDA and Health Canada regulatory and applicable laws and regulations, as well as of cGMP standards.
- Proven regulatory advocacy skills with measurable deliverables in OTC/ Medical Device space in US.
- Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as, internal and external stakeholders
- Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
- Self-motivated with critical attention to detail, deadlines and reporting
- Excellent English written and verbal communication skills.
If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.