Designation: Sr. Manager - Regulatory Affairs

Work location: Corporate Office, Hyderabad

Reporting to: SBU Head

Company :

Sarvotham Care Limited is a leading Contract Development and Manufacturing Organization (CDMO) founded in 1996 in Hyderabad, India. We offer end-to-end services from R&D to Manufacturing for healthcare (nutraceuticals and health supplements under FSSAI, botanicals under AYUSH, and Pharma OTC), personal care and cosmetics, home care, and hospital care products. We have state-of-the-art R&D and manufacturing facilities in Hyderabad and Himachal Pradesh. We serve our globe clients such as GSK, Haleon, Himalaya, Amway, P&G, DRL, Ayurveda Co, NuEva, and AJ Drugs.

We are committed to providing our clients with high-quality products and services that meet their needs. We are also committed to social responsibility and sustainability. We have been recognized globally for our excellence in innovation, quality, and customer satisfaction and appreciated by our clients.

We are an Equal Employment Opportunity provider with a team professional experts. We value our employees as our greatest asset and business partners. We offer a great culture, salary and benefits package that includes free health and accidental insurances, work-life balance, competitive working environment, and opportunities for professional development and growth.

With huge growth plans for 2024, Sarvotham is currently searching for an experienced Regulatory Affairs professional to ensure compliance with global market regulatory requirements and obtain necessary accreditations to maintain high standards.

Responsibilities (not limited to.) :

- Identify, apply for, and maintain relevant global accreditations and certifications of any country or region specific requirements that affect our business.

- Monitor and interpret regulations, policies, and guidelines related to product safety, labelling, ingredients, packaging, claims, and any other applicable regulatory requirements. Ensure that the customer's and company's products meet all necessary compliance standards.

- Coordinate and prepare regulatory submissions, applications, and dossiers required for product registrations, licenses, permits, or approvals. This includes compiling technical data, safety assessments, labelling requirements, and any other documentation needed for regulatory submissions.

- Create, maintain, and update regulatory documentation, including product information files, technical files, regulatory databases, and records of regulatory activities. Ensure that all documentation is accurate, and easily accessible for internal and external audits or inspections.

- Serve as the primary point of contact with regulatory authorities, government agencies, and industry associations, to respond queries, providing requested information, and coordinating regulatory inspections or audits.

- Work closely with various departments, including R&D, manufacturing, quality assurance, BD to ensure regulatory compliance throughout the product lifecycle. Provide regulatory guidance and support to these teams, review product specifications, labelling, and claims and advise on regulatory implications for new product development or modifications.

- Develop regulatory strategies and policies to support business objectives while ensuring compliance. This includes assessing the regulatory impact of proposed changes, identifying potential risks or obstacles, and recommending appropriate courses of action to address them.

- Conduct internal audits to assess compliance with regulatory requirements and identify areas for improvement.

- Develop and deliver training programs to educate employees on regulatory obligations, changes in regulations, and best practices.

- Stay abreast of industry trends, regulatory developments, and emerging issues that affect our business, and update the same to the respective stakeholders. This includes participating in industry forums, attending conferences, and maintaining a network of contacts within the regulatory community.

Requirements :

- Master Graduation in Science, Pharma, Physiology, Biochemistry, or Ayurveda. A Diploma in Regulatory Affairs will be an added advantage.

- 10-15 years of experience with a minimum of 5 years of managerial experience in handling regulatory affairs, and obtaining certifications and accreditations independently in Nutraceuticals and Phyto pharma products under license of AYUSH, FSSAI, FDA with added advantage in managing international regulatory agencies like NHP Canada, EU, UK, Malaysia and etc.

- Expertise on end-to-end global regulatory requirements such as GMP, ISO, FDA, EMA, WHO, FSSAI, TGA, HALAL, UAE, AYUSH, SEAT, PIC/S or any country or region specific requirements.

- Excellent communication skills, interpersonal skills, collaborate with cross-functional teams and concerned regulatory authorities.

- Excellent project management and organising skills, with the ability to prioritize and drive multiple initiatives simultaneously.

- Exceptional presentation skills, with the ability to effectively covey complex concepts to the concerned stakeholders.

Benefits :

A competitive salary package and the opportunity to shape the future of our business plans.

If you are passionate about the job, thrive in a dynamic and entrepreneurial environment, and possess a strong drive for success, we should love to hear from you.

Screening :

- Interaction by the HR to understand the basic requirements

- HR Head discussions to understand the personal strengths and capabilities to perform the job, compensation, and on-boarding requirements on online

- Discussions with the leadership panel either online or personal

- Discussions with the Directors, based on the requirement

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