San Francisco, CA -- Conselium is currently seeking qualified candidates in the San Francisco area to fill the Manager of Regulatory Affairs job opening at a growing International Biotech company.
Manager of Regulatory Affairs
International Biotech Company
Los Angeles, CA
We
are representing an International Biotech company experiencing 4%
revenue growth and 20% employee growth. The Company has a blockbuster
drug that has been approved for marketing in over 40 counties yet we
have only distributed to nine….so revenues will continue to grow.
Responsibilities of Manager of Regulatory Affairs:
Produce
high quality global regulatory submissions with minimal supervision.
Provide regulatory guidance to management and regulatory scientists.
Participate and provide regulatory guidance in development and
marketing team meetings. The Manager of Regulatory Affairs will report
to the Senior Director of Regulatory Affairs.
- Compile high quality global regulatory submissions, including INDs, NDAs, MAAs, CTAs on time and within department budgets.
- Ensure regulatory compliance is maintained or enhanced for the incumbent’s areas of regulatory responsibility.
- Maintain currency in US & EU regulatory guidelines
- Provide regulatory guidance to the department and to the development and marketing project teams.
- Train
and mentor regulatory staff and external departments, as appropriate,
on issues that impact the quality of regulatory submissions.
- Review
and interpret new guidances and assess their impact on drug
development, the regulatory and/or other relevant departments, and on
the company.
- Review and approve change control documents and provide an assessment of regulatory impact.
- Devise regulatory submission strategies in accordance with regulatory requirements and company objectives.
Requirements of Manager of Regulatory Affairs:
- Bachelors degree in a relevant science subject.
- Minimum
of 5 years of experience in a drug regulatory affairs department of a
pharmaceutical or biopharmaceutical drug company or equivalent.
- Evidence of a significant role in the compilation, submission, regulatory submissions to the FDA.
- An in-depth knowledge of FDA regulations and guidelines is required.
- Working knowledge of electronic submission requirements.
Relocation Provided
Qualified Candidates in San Francisco (and surrounding areas):
• Submit resume as a WORD document along with compensation requirements.
• Submit resume to Maurice Gilbert at maurice@conselium.com
